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510(k) Data Aggregation

    K Number
    K160585
    Device Name
    XN CAL
    Manufacturer
    Streck
    Date Cleared
    2016-12-22

    (296 days)

    Product Code
    KRX, PAN
    Regulation Number
    864.8150
    Why did this record match?
    Product Code :

    KRX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    XN CAL is used for the calibration and calibration verification of Sysmex XN series (XN-10, XN-11, XN-20, XN-21, XN-L) analyzers. Assayed parameters include: WBC (10^3/μL), RBC (10^6/μL), HGB (g/dL), HCT (%), PLT (10^3/ μL), and RET (%)
    Device Description
    XN CAL contains the following: stabilized red blood cell component(s), stabilized white blood cell component(s), stabilized platelet component(s), and stabilized nucleated red blood cell component(s) in a preservative medium.
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    K Number
    K141955
    Device Name
    XN CAL PF
    Manufacturer
    Streck
    Date Cleared
    2014-12-05

    (140 days)

    Product Code
    KRX, PAN
    Regulation Number
    864.8150
    Why did this record match?
    Product Code :

    KRX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    XN CAL PF is used for the calibration and calibration verification of Sysmex XN series (XN-10, XN-11, XN-20, XN-21) analyzers. Assayed parameters include: PLT-F (10^3/ uL)
    Device Description
    XN CAL PF contains the following: stabilized red blood cell component(s), and stabilized platelet component(s) in a preservative medium.
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    K Number
    K141962
    Device Name
    XN CAL
    Manufacturer
    Streck
    Date Cleared
    2014-12-05

    (140 days)

    Product Code
    KRX, PAN
    Regulation Number
    864.8150
    Why did this record match?
    Product Code :

    KRX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    XN CAL is used for the calibration and calibration verification of Sysmex XN series (XN-10, XN-11, XN-20, XN-21) analyzers. Assayed parameters include: WBC (10^3/uL), RBC (10^6/uL), HGB (g/dL), HCT (%), PLT (10^3/ uL), and RET (%)
    Device Description
    XN CAL contains the following: stabilized red blood cell component(s), stabilized white blood cell component(s), stabilized platelet component(s), and stabilized nucleated red blood cell component(s) in a preservative medium.
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    K Number
    K120747
    Device Name
    XN CAL PF
    Manufacturer
    Streck
    Date Cleared
    2012-10-22

    (224 days)

    Product Code
    KRX
    Regulation Number
    864.8150
    Why did this record match?
    Product Code :

    KRX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    XN CAL PF is used for calibration and calibration verification of Sysmex XN series (XN-10, XN-20) analyzers. The assayed parameter is: PLT-F (103/pL)
    Device Description
    XN CAL™ PF is an in-vitro diagnostic product that contains the following: stabilized red blood cell component(s), and stabilized platelet component(s) in a preservative medium. The product is packaged in polypropylene plastic vials with screw caps containing 3 ml. The vials will be packaged in (5) welled or (1) welled vacuum formed clamshell container with the Instructions for Use / assay sheet. The product must be stored at 2 - 8° C.
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    K Number
    K120745
    Device Name
    XN CAL
    Manufacturer
    Streck
    Date Cleared
    2012-10-19

    (221 days)

    Product Code
    KRX
    Regulation Number
    864.8150
    Why did this record match?
    Product Code :

    KRX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    XN CAL is used for the calibration and calibration verification of Sysmex XN series (XN-10, XN-20) analyzers. Assayed parameters include: WBC (103/μL), RBC (108/μL), HGB (g/dL), HCT (%), PLT (103/ μL), and RET (%)
    Device Description
    XN CAL™ is an in-vitro diagnostic product that contains the following: stabilized red blood cell component(s), stabilized white blood cell component(s), stabilized platelet component(s), and stabilized nucleated red blood cell component(s) in a preservative medium. The product is packaged in polypropylene plastic vials with screw caps containing 3 ml. The vials will be packaged in (5) welled or (1) welled vacuum formed clamshell container with the Instructions for Use (IFU) / assay sheet. The product must be stored at 2 - 8° C.
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    K Number
    K111204
    Device Name
    CELL-DYN 22 PLUS CALIBRATOR
    Manufacturer
    Streck
    Date Cleared
    2011-12-22

    (237 days)

    Product Code
    KRX
    Regulation Number
    864.8150
    Why did this record match?
    Product Code :

    KRX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    CELL-DYN 22 Plus Calibrator is manufactured for calibration of the CELL-DYN Emerald 22 system. Assayed parameters include: WBC (109/L), RBC (1012/L), HGB (g/dL), MCV (fL), PLT (109/L)
    Device Description
    CELL-DYN 22 Plus Calibrator is an in-vitro diagnostic product that may contain any or all of the following: stabilized human or mammalian red blood cells, human, mammalian or simulated white blood cells and a platelet component in a preservative medium. The product is packaged in polypropylene plastic vials containing 2.5ml. The closures are polypropylene screw caps with polyethylene liners. The vials will be packaged in a four (4) welled vacuum formed clamshell container with the package insert / assay sheet. The product must be stored at 2 - 10° C.
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    K Number
    K083200
    Device Name
    X-CAL
    Manufacturer
    Streck
    Date Cleared
    2009-02-03

    (96 days)

    Product Code
    KRX
    Regulation Number
    864.8150
    Why did this record match?
    Product Code :

    KRX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    X-Cal is used to calibrate and verify calibration of Sysmex hematology analyzers. Refer to product assay sheet.
    Device Description
    X-Cal is a stabilized suspension of human and animal blood, in a solution containing biological salts and anti-microbial preservatives. The product is packaged in plastic vials containing 4.5 ml. The closures are polypropylene screw caps with polyethylene liners. The vials will be packaged in a five welled vacuum formed "clamshell" container. The product must be stored at 2 - 8℃.
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    K Number
    K020469
    Device Name
    CAL-CHEX CD PLUS
    Manufacturer
    STRECK LABORATORIES, INC.
    Date Cleared
    2002-04-04

    (51 days)

    Product Code
    KRX, KRY, KRZ, KSA
    Regulation Number
    864.8150
    Why did this record match?
    Product Code :

    KRX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Cal-Chex CD Plus is intended to be used as a calibrator for the calibration of WBC, RBC, Hgb, MCV, PLT and MPV (MPV on CD4000 only) on the Abbott Cell-Dyn 3200 and 4000 hematology instruments.
    Device Description
    Cal-Chex CD Plus is a suspension of stabilized human red blood cells, human white blood cells, and human platelets packaged in glass vials containing 3.0 mL volumes. Closures are injection molded polypropylene screw-top caps. The vials are packaged in a PVC clamshell.
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    K Number
    K003991
    Device Name
    CD-CAL PLUS CALIBRATOR
    Manufacturer
    R & D SYSTEMS, INC.
    Date Cleared
    2001-01-16

    (21 days)

    Product Code
    KRX, KRY, KRZ, KSA
    Regulation Number
    864.8150
    Why did this record match?
    Product Code :

    KRX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K993375
    Device Name
    CDS LTX CONTROL LATEX PARTICLE SUSPENSION AND PRIMER
    Manufacturer
    CLINICAL DIAGNOSTIC SOLUTIONS, INC.
    Date Cleared
    1999-12-20

    (74 days)

    Product Code
    KRX, KRY, KRZ, KSA
    Regulation Number
    864.8150
    Why did this record match?
    Product Code :

    KRX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    CDS LTX-Control Latex Particle Suspension is intended to serve as a calibration standard for the d.c. impedance, r.f. impedance and optical light scatter parameters of the VCS module of Coulter® Models STKS, MAXM and Gen.S Hematology Analyzer systems. Models STKS and MAXM analyzers equipped with 5-part differential capability only require aspiration of the CDS LTX-Control Latex Particle Suspension through the secondary mode aspiration inlet with the analyzer set to function F5S. STKS and Gen. S analyzers equipped with 5-part differential and reticulocyte capability require aspiration of the CDS LTX-Control Latex Particle Suspension through the secondary mode aspiration inlet with the analyzer set to function F57.
    Device Description
    The CDS LTX-Control for red cell, white cell, and platelet counting is a device that resembles red cells, white cells, and platelets, and is used to validate the electronic calibration of the volume, conductivity and light scatter parameters on Coulter® MAXM®, STKS® and GEN.S® instruments intended to count red cells, whire cells, and platelets. It is a suspension of uniform particles whose shape, size, and concentration and other characteristics have been precisely and accurately determined. CDS LTX-Control is supplied as ready-to-use latex particles in a buffered suspension fluid. The particles pass through the flow cell producing characteristic electrical signals that are measured as volume, conductivity and light scatter for quality monitoring of the previously mentioned COULTER instruments. Matrix base - aqueous, buffered, bacteriostatic and fungistatic medium containing a surfactant. Constituents - alkali metal salts, detergents, antimicrobial materials and polymer beads of known size.
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