BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    PRIMUS VARIANT SYSTEM PVS99

    K Number: K955283 · Decision Mar 1, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    22
    Applicant Total
    11
    Review Days
    106

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    Basic Information

    Device Name
    PRIMUS VARIANT SYSTEM PVS99
    K Number
    K955283
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.7415
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Primus Corp.
    Date Received
    November 16, 1995
    Decision Date
    March 1, 1996
    Product Code
    GKA
    Advisory Committee
    Hematology
    Review Advisory Committee
    HE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    GKA Abnormal Hemoglobin Quantitation

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    Other Clearances by Primus Corp.

    K Number Device Name
    K062658 PRIMUS A1CARE ASSAY
    K013787 NYCOCARD CRP
    K014084 NYCOCARD CRP CONTROL
    K994045 PRIMUS LIQUID CALIBRATOR FOR GHB/A1C LEVEL 1 AND LEVEL 2
    K992921 PRIMUS LIQUID CONTROL FOR GHB/ALC LEVEL I AND LEVEL II
    K942009 PRIMUS RAPID GEL 100 GLYCATED HEMOGLOBIN ASSAY
    K940008 GLYCATED PROTEIN CALIBRATORS
    K940142 GLYCATED PROTEIN CONTROLS
    K936204 GLYCATED HEMOGLOBIN CALIBRATORS
    K940143 GLYCATED HEMOGLOBIN CONTROLS
    Search all 11 clearances from Primus Corp. →