BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    CARESIDE GGT

    K Number: K020486 · Decision Jul 1, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18
    Same Product Code
    32
    Applicant Total
    22
    Review Days
    138

    Basic Information

    Device Name
    CARESIDE GGT
    K Number
    K020486
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1360
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Careside, Inc.
    Date Received
    February 13, 2002
    Decision Date
    July 1, 2002
    Product Code
    JPZ
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

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

    Product Code Device Name
    JPZ Colorimetric Method, Gamma-Glutamyl Transpeptidase

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (JPZ), ordered by most recent decision date.

    DMA GAMMA GLUTAMYLTRANSFERASE (GGT) PROCEDURE

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    GAMMA-GT

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    KING DIAGNOSTICS GAMMA GT REAGENT

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    GGT REAGENT

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    ROCHE COBAS READY GGT REAGENT

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    ELITECH GAMMA GT TEST KIT

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry
    View all

    Other Clearances by Careside, Inc.

    K Number Device Name
    K020484 CARESIDE LDH
    K020487 CARESIDE ALT
    K020488 CARESIDE TRGLYCERIDE
    K002792 CARESIDE CHOLINESTERASE
    K001462 CARESIDE HEMOGLOBIN
    K993771 CARESIDE DIRECT BILIRUBIN
    K993634 CARESIDE ANALYZER
    K992475 CARESIDE CO2, TOTAL
    K991717 CARESIDE MG
    K991371 CARESIDE AMMONIA
    Search all 22 clearances from Careside, Inc. →