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

    VITROS IMMUNODIAGNOSTIC PRODUCTS PROLACTIN REAGENT PACK/CALIBRATORS

    K Number: K970281 · Decision Feb 25, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    52
    Registration Numbers
    52
    Same Product Code
    79
    Applicant Total
    33
    Review Days
    32

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    Basic Information

    Device Name
    VITROS IMMUNODIAGNOSTIC PRODUCTS PROLACTIN REAGENT PACK/CALIBRATORS
    K Number
    K970281
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1625
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Johnson & Johnson Clinical Diagnostics, Inc.
    Date Received
    January 24, 1997
    Decision Date
    February 25, 1997
    Product Code
    CFT
    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
    CFT Radioimmunoassay, Prolactin (Lactogen)

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    Other Clearances by Johnson & Johnson Clinical Diagnostics, Inc.

    K Number Device Name
    K980283 VITROS CHEMISTRY PRODUCTS CRBM SLIDES
    K974644 VITROS IMMUNODIAGNOSTIC PRODUCTS RANGE VERIFIERS
    K973517 VITROS IMMUNODIAGNOSTIC PRODUCTS RANGE VERIFIERS
    K973030 VITROS IMMUNODIAGNOSTICS PRODUCTS/CK-MB REAGENT PACK(GEM.1300)/CK-MB CALIBRATORS (GEM.C300)
    K972133 VITROS IMMUNODIAGNOSTICS PRODUCTS PROGESTERONE REAGENT PACK (GEM.1070), PROGESTERONE CALIBRATORS (GEM.C070)
    K970894 VITROS IMMUNODIAGNOSTICS PRODUCTS TOTAL B-HCG REAGENT PACK (GEM.1075), TOTAL B-HCG CALIBRATORS (GEM.C075)
    K970643 VITROS IMMUNODIAGNOSTICS PRODUCTS ESTRADIOL REAGENT PACK(GEM. 1050)/ESTRADIOL CALIBRATORS (GEM.C050)
    K965142 VITROS IMMUNODIAGNOSTICS PRODUCTS FREE T4 REAGENT PACK (GEM.1015) FREE T4 CALIBRATORS (GEM.CO15)
    K964982 VITROS IMMUNODIAGNOSTICS PRODUCTS LH REAGENT PACK (GEM.1055) AND LH CALIBRATORS (GEM.CO55)
    K964960 VITROS CHEMISTRY PRODUCTS UPRO SLIDES
    Search all 33 clearances from Johnson & Johnson Clinical Diagnostics, Inc. →