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

    VITROS IMMUNODDIAGNOSTICS PRODUCTS RE CONTROLS (GEM.5015)

    K Number: K965048 · Decision Jan 27, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    127
    Registration Numbers
    127
    Same Product Code
    672
    Applicant Total
    33
    Review Days
    40

    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 IMMUNODDIAGNOSTICS PRODUCTS RE CONTROLS (GEM.5015)
    K Number
    K965048
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1660
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Johnson & Johnson Clinical Diagnostics, Inc.
    Date Received
    December 18, 1996
    Decision Date
    January 27, 1997
    Product Code
    JJY
    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
    JJY Multi-Analyte Controls, All Kinds (Assayed)

    Similar 510(k) Clearances

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

    Multichem IA Plus

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    Audit MicroControls Linearity FD Tumor Markers II

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    Liquichek Tumor Marker Control-Level 1; Liquichek Tumor Marker Control-Level 2; Liquichek Tumor Marker Control-Level 3; Liquichek Tumor Marker Control- Trilevel MiniPak

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    VK-3 Verification Kit, VK-4 Verification Kit, VK-R5 Verification Kit, VK-R7 Verification Kit, VK-Crea Verification Kit

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    Liquichek Cardiac Markers Plus Control LT

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    VALIDATE Anemia Calibration Verification/ Linearity Test Kit

    FDA 510(k)
    FDA Class 1 ·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. →