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

    VITROS IMMUNODIAGNOSTICS PRODUCTS/TSH REAGENT PACK (GEM. 1001)/TSH CALIBRATORS(GEM.C001)

    K Number: K964558 · Decision Dec 16, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    73
    Registration Numbers
    73
    Same Product Code
    241
    Applicant Total
    33
    Review Days
    33

    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/TSH REAGENT PACK (GEM. 1001)/TSH CALIBRATORS(GEM.C001)
    K Number
    K964558
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1690
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Johnson & Johnson Clinical Diagnostics, Inc.
    Date Received
    November 13, 1996
    Decision Date
    December 16, 1996
    Product Code
    JLW
    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
    JLW Radioimmunoassay, Thyroid-Stimulating Hormone

    Similar 510(k) Clearances

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

    Atellica® IM TSH3-Ultra II (TSH3ULII)

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Dimension LOCI Thyroid Stimulating Hormone Flex reagent cartridge (TSHL); Dimension LOCI Free Thyroxine Flex reagent cartridge (FT4L)

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Maverick Diagnostic System TC1000; Maverick Test Panel A0.B0

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ADVIA Centaur® TSH3-Ultra II (TSH3ULII)

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Atellica® CI Analyzer, Atellica® IMThyroid Stimulating Hormone 3-Ultra (TSH3-UL), Atellica® CH Albumin BCP (AlbP)

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Access TSH (3rd IS) Assay, DxI 9000 Access Immunoassay Analyzer

    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. →