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

    DU PONT VCA-IGM ANTIBODY ELISA KIT

    K Number: K875204 · Decision Jul 8, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    22
    Applicant Total
    253
    Review Days
    203

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    Basic Information

    Device Name
    DU PONT VCA-IGM ANTIBODY ELISA KIT
    K Number
    K875204
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.3235
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    E.I. Dupont DE Nemours & Co., Inc.
    Date Received
    December 18, 1987
    Decision Date
    July 8, 1988
    Product Code
    LJN
    Advisory Committee
    Microbiology
    Review Advisory Committee
    MI
    Third Party
    N

    Classifications

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

    Product Code Device Name
    LJN Antibody Igm, If, Epstein-Barr Virus

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    Other Clearances by E.I. Dupont DE Nemours & Co., Inc.

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    K951441 DUPONT ACA DIGOXIN (DGN A) METHOD
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    K950135 URINE AMPHETAMINES SCREEN FLEX(TM) REAGENT CARTRIDGE
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    K950134 URINE COCAINE METABOLITE SCREEN FLEX(TM) REAGENT CATRIDGE
    Search all 253 clearances from E.I. Dupont DE Nemours & Co., Inc. →