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510(k) Data Aggregation
K Number
K160585Device Name
XN CAL
Manufacturer
Streck
Date Cleared
2016-12-22
(296 days)
Product Code
KRX, PAN
Regulation Number
864.8150Why did this record match?
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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
K141955Device Name
XN CAL PF
Manufacturer
Streck
Date Cleared
2014-12-05
(140 days)
Product Code
KRX, PAN
Regulation Number
864.8150Why did this record match?
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Matched: '864.8150'
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
K141962Device Name
XN CAL
Manufacturer
Streck
Date Cleared
2014-12-05
(140 days)
Product Code
KRX, PAN
Regulation Number
864.8150Why did this record match?
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Matched: '864.8150'
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
K120747Device Name
XN CAL PF
Manufacturer
Streck
Date Cleared
2012-10-22
(224 days)
Product Code
KRX
Regulation Number
864.8150Why did this record match?
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Matched: '864.8150'
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
K120745Device Name
XN CAL
Manufacturer
Streck
Date Cleared
2012-10-19
(221 days)
Product Code
KRX
Regulation Number
864.8150Why did this record match?
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Matched: '864.8150'
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
K111204Device Name
CELL-DYN 22 PLUS CALIBRATOR
Manufacturer
Streck
Date Cleared
2011-12-22
(237 days)
Product Code
KRX
Regulation Number
864.8150Why did this record match?
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Matched: '864.8150'
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
K083200Device Name
X-CAL
Manufacturer
Streck
Date Cleared
2009-02-03
(96 days)
Product Code
KRX
Regulation Number
864.8150Why did this record match?
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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
K020469Device Name
CAL-CHEX CD PLUS
Manufacturer
STRECK LABORATORIES, INC.
Date Cleared
2002-04-04
(51 days)
Product Code
KRX, KRY, KRZ, KSA
Regulation Number
864.8150Why did this record match?
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Matched: '864.8150'
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
K993375Device 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
864.8150Why did this record match?
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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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