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

    VITROS IMMUNODIAGNOSTIC SYSTEM

    K Number: K962919 · Decision Oct 18, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    51
    Registration Numbers
    51
    Same Product Code
    37
    Applicant Total
    33
    Review Days
    84

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    Basic Information

    Device Name
    VITROS IMMUNODIAGNOSTIC SYSTEM
    K Number
    K962919
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.2560
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Johnson & Johnson Clinical Diagnostics, Inc.
    Date Received
    July 26, 1996
    Decision Date
    October 18, 1996
    Product Code
    KHO
    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
    KHO Fluorometer, For Clinical Use

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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)
    K970281 VITROS IMMUNODIAGNOSTIC PRODUCTS PROLACTIN REAGENT PACK/CALIBRATORS
    K964982 VITROS IMMUNODIAGNOSTICS PRODUCTS LH REAGENT PACK (GEM.1055) AND LH CALIBRATORS (GEM.CO55)
    Search all 33 clearances from Johnson & Johnson Clinical Diagnostics, Inc. →