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510(k) Data Aggregation

    K Number
    K042587
    Device Name
    RETIC-CHEX FOR CELL-DYN
    Manufacturer
    STRECK LABORATORIES, INC.
    Date Cleared
    2004-10-19

    (27 days)

    Product Code
    JPK
    Regulation Number
    864.8625
    Why did this record match?
    Applicant Name (Manufacturer) :

    STRECK LABORATORIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Retic-Chex for Cell-Dyn is an assayed control for evaluating the accuracy and precision of automated, semi-automated and manual methods of reticulocyte counting.
    Device Description
    Retic-Chex for Cell-Dyn is a suspension of stabilized human red blood cells and simulated human reticulocytes packaged in plastic vials containing 1.0ml volumes. The device consists of two levels of reticulocyte percentage range. Control I reticulocyte percent range will be 1.5 - 2.0. Control II reticulocyte percent range will be 3.9 - 5.8. Closures are injection molded polypropylene screw-top caps. The vials are packaged in vacuum molded clam-shell box.
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    K Number
    K040107
    Device Name
    CYTO-CHEX BCT
    Manufacturer
    STRECK LABORATORIES, INC.
    Date Cleared
    2004-07-27

    (189 days)

    Product Code
    JKA
    Regulation Number
    862.1675
    Why did this record match?
    Applicant Name (Manufacturer) :

    STRECK LABORATORIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Cyto-Chex® BCT is intended for the collection and storage of blood specimens for immunophenotyping of WBC by flow-cytometry. Recovery of lymphocyte subset cell markers of the HIV panel can be accomplished over a 7 day period following collection.
    Device Description
    Cyto-Chex BCT consists of a standard 13 x 75mm glass blood collection tube containing 57ul of sterile K,EDTA anti-coagulant and WBC preservative. It is manufactured with a vacuum to draw 5ml of blood by venipuncture.
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    K Number
    K040025
    Device Name
    A1C-CELLULAR
    Manufacturer
    STRECK LABORATORIES, INC.
    Date Cleared
    2004-03-02

    (55 days)

    Product Code
    JJX
    Regulation Number
    862.1660
    Why did this record match?
    Applicant Name (Manufacturer) :

    STRECK LABORATORIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A1c-Chex is a bi-level whole blood based, assayed control for monitoring performance of analysis procedures for HbA1c.
    Device Description
    A1c-Chex is bi-level, whole blood based, assayed control for monitoring performance of tastal A IC-Chex is blevel, whole blood, acouryed of he same as a patient specimen and tested procedures for ribATC. ATT offex brith the instrument, kit or reagent being used. A1c-Chex following the instructions included with the including in oversion of analysis procedures, including lysing of the RBC.
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    K Number
    K023656
    Device Name
    SICKLE-CHEX SOLUBILITY KIT
    Manufacturer
    STRECK LABORATORIES, INC.
    Date Cleared
    2002-12-30

    (61 days)

    Product Code
    GHM
    Regulation Number
    864.7825
    Why did this record match?
    Applicant Name (Manufacturer) :

    STRECK LABORATORIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Sickle-Chex Solubility Kit is a qualitative solubility test kit for tasting the presence of sickling hemoglobins in human blood or sickle cell control materlal.
    Device Description
    Sickle-Chex Solubility Kit consists of: - Sickle-Chex Solubility Buffer; two LDPE bottles, each illied ville 100mL of a A. 2.3M potassium phosphate buffer solution containing Saponin. - Sickle-Chex Reagent Powder; two glass vials, each filled with 4 grams of B. Sodium Hydrosulfite. The testing principles of the kit is based on NCCLS, H10-F.
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    K Number
    K021922
    Device Name
    MODIFICATION TO PARA 5X
    Manufacturer
    STRECK LABORATORIES, INC.
    Date Cleared
    2002-06-25

    (14 days)

    Product Code
    JPK
    Regulation Number
    864.8625
    Why did this record match?
    Applicant Name (Manufacturer) :

    STRECK LABORATORIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Para 5X is intended for use as a multi-parameter quality control material for ABX Pentra 60 C+ and Beckman Coulter™ AcT™ hematology analyzers. It includes assay values for CBC/Diff parameters.
    Device Description
    Para® 5X is a tri-level multi-parameter hematology control consisting of stabilized human red blood cells, human white blood cells and simulated platelets. The product is packaged in glass vials containing 3 ml. The closures are polypropylene screw caps with pierceable liners.
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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?
    Applicant Name (Manufacturer) :

    STRECK LABORATORIES, INC.

    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
    K013316
    Device Name
    SICKLE-CHEX
    Manufacturer
    STRECK LABORATORIES, INC.
    Date Cleared
    2001-11-06

    (33 days)

    Product Code
    GHM
    Regulation Number
    864.7825
    Why did this record match?
    Applicant Name (Manufacturer) :

    STRECK LABORATORIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Sickle-Chex is intended to be used as a sickle cell control in testing for the presence of hemoglobin S in solubility tests and hemoglobin electrophoresis.
    Device Description
    Sickle-Chex consists of Control materials for verifying performance of sickle cell hemoglobin testing systems. The controls contain human red blood cells and preservative suspension media packaged in a polyethylene dropper bottle with dispensing tip. Product fill is 2.5 ml per vial.
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    K Number
    K011410
    Device Name
    PARA 5X
    Manufacturer
    STRECK LABORATORIES, INC.
    Date Cleared
    2001-06-26

    (49 days)

    Product Code
    JPK
    Regulation Number
    864.8625
    Why did this record match?
    Applicant Name (Manufacturer) :

    STRECK LABORATORIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K001443
    Device Name
    SUGAR CHEX ONE
    Manufacturer
    STRECK LABORATORIES, INC.
    Date Cleared
    2000-06-29

    (52 days)

    Product Code
    JJX
    Regulation Number
    862.1660
    Why did this record match?
    Applicant Name (Manufacturer) :

    STRECK LABORATORIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K000945
    Device Name
    PARA 12 PLUS RETICS
    Manufacturer
    STRECK LABORATORIES, INC.
    Date Cleared
    2000-04-18

    (26 days)

    Product Code
    GLQ
    Regulation Number
    864.8625
    Why did this record match?
    Applicant Name (Manufacturer) :

    STRECK LABORATORIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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