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510(k) Data Aggregation

    K Number
    K080016
    Device Name
    NRBC-CHEX FOR ADVIA
    Manufacturer
    Streck
    Date Cleared
    2008-02-05

    (33 days)

    Product Code
    GJR
    Regulation Number
    864.8625
    Why did this record match?
    Product Code :

    GJR

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    nRBC-Chex for ADVIA® is an assayed whole blood control designed to evaluate the accuracy and precision of the Siemens Healthcare Diagnostics Inc. hematology analyzers in the measurement of the nucleated red blood cell parameter. Refer to product assay sheet.
    Device Description
    nRBC-Chex for ADVIA® is 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 4ml. The closures are polypropylene screw caps with polyethylene liners. There are two different levels. Level 1 has a low count and Level 2 has a higher count. The vials will be packaged in a two (2) or twelve (12) welled vacuum formed "clam-shell" container with the package insert / assay sheet. The product must be stored at 2 - 10°C.
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    K Number
    K060083
    Device Name
    NRBC-CHEX FOR LH
    Manufacturer
    Streck
    Date Cleared
    2006-02-09

    (29 days)

    Product Code
    GJR, GGL
    Regulation Number
    864.8625
    Why did this record match?
    Product Code :

    GJR

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    nRBC-Chex for LH is an assayed whole blood control designed to evaluate the accuracy and precision of the Beckman Coulter® LH 750 in its measurement of the nucleated red blood cell parameter.
    Device Description
    nRBC-Chex for LH is 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 4ml. The closures are polypropylene screw caps with polyethylene liners. There are two different levels. Level 1 has a low count and Level 2 has a higher count. The vials will be packaged in a six (6) or twelve (12) welled vacuum formed "clam-shell" container with the package in a sk (v) product must be stored at 2 - 10°C.
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    K Number
    K000076
    Device Name
    CELL-CHEX
    Manufacturer
    STRECK LABORATORIES, INC.
    Date Cleared
    2000-03-03

    (53 days)

    Product Code
    GJR
    Regulation Number
    864.8625
    Why did this record match?
    Product Code :

    GJR

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

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