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

    SGOT/ALT REAGENT

    K Number: K852783 · Decision Jul 22, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    50
    Registration Numbers
    50
    Same Product Code
    138
    Applicant Total
    21
    Review Days
    21

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    Basic Information

    Device Name
    SGOT/ALT REAGENT
    K Number
    K852783
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1100
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Advanced Biomedical Methods, Inc.
    Date Received
    July 1, 1985
    Decision Date
    July 22, 1985
    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 Advanced Biomedical Methods, Inc.

    K Number Device Name
    K945353 CLARIT(TM)
    K880949 SINGLE REAGENT CALCIUM FOR DEMAND ANALYZER
    K864866 RESUBMISSION OF THE KLEERZIT REAGENT
    K852784 ALKALINE PHOSPHATASE
    K852027 GGTP REAGENT/SERUM IRON/SALICYLATE DEMAND ANALYZER
    K850380 INORGANIC PHOSPHOROUS FOR DEMAND ANALYZER
    K850379 DIRECT BILIRUBIN FOR DEMAND ANALYZER
    K850378 LDH REAGENT FOR DEMAND ANALYZER
    K850381 MAGNESIUM REAGENT FOR DEMAND ANALYZER
    K844331 TOTAL PROTEIN REAGENT FOR DEMAND ANALYZER
    Search all 21 clearances from Advanced Biomedical Methods, Inc. →