BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    ASPARTATE AMINOTRANSFERASE ASSAY KIT (IFCC)

    K Number: K880692 · Decision May 27, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    50
    Registration Numbers
    50
    Same Product Code
    138
    Applicant Total
    77
    Review Days
    95

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    Basic Information

    Device Name
    ASPARTATE AMINOTRANSFERASE ASSAY KIT (IFCC)
    K Number
    K880692
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1100
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Diagnostic Chemicals, Ltd. (Usa)
    Date Received
    February 22, 1988
    Decision Date
    May 27, 1988
    Product Code
    CIT
    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
    CIT Nadh Oxidation/Nad Reduction, Ast/Sgot

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    Other Clearances by Diagnostic Chemicals, Ltd. (Usa)

    K Number Device Name
    K022538 IMMUNODIP URINARY ALBUMIN SCREEN ASSAY, CATALOGUE NUMBER 790-25
    K974874 BILIRUBIN-SL (TOTAL) ASSAY
    K932556 AMMONIA ASSAY CAT. NO. 200-02
    K932766 HDL-CHOLESTRAL(DEXTRAN SULFATE/MAGNESIUM)
    K932555 DC-LINEATE CAT. NO. SE-091
    K925877 DC-UIBC-CAL
    K912825 MAGNESIUM ASSAY KIT, CAT.# 100-12
    K895964 DCL SYPHILIS-M CATALOG NO. 600-80
    K895965 DCL - SYPHILIS-G ASSAY CATALOG NO. 600-70
    K904660 ENZYMATIC BILIRUBIN (TOTAL), CATALOGUE NO. 202-14
    Search all 77 clearances from Diagnostic Chemicals, Ltd. (Usa) →