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

    VITROS IMMUNODIAGNOSTICS PRODUCTS T3 UPTAKE REAGENT PACK (GEM.1025) AND T3 UPTAKE CALIBRATORS (GEM.C025)

    K Number: K964308 · Decision Nov 27, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    33
    Registration Numbers
    33
    Same Product Code
    92
    Applicant Total
    33
    Review Days
    29

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    VITROS IMMUNODIAGNOSTICS PRODUCTS T3 UPTAKE REAGENT PACK (GEM.1025) AND T3 UPTAKE CALIBRATORS (GEM.C025)
    K Number
    K964308
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1715
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Johnson & Johnson Clinical Diagnostics, Inc.
    Date Received
    October 29, 1996
    Decision Date
    November 27, 1996
    Product Code
    KHQ
    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
    KHQ Radioassay, Triiodothyronine Uptake

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (KHQ), ordered by most recent decision date.

    ACE T UPTAKE REAGENT TU CALIBRATORS

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    T-UPTAKE MICROPLATE EIA

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    CHIRON DIAGNOSTICS ACS:180TU P

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ELECSYS T-UPTAKE ASSAY

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    CEDIA T UPTAKE ASSAY

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    T-UPTAKE EIA TEST

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry
    View all

    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. →