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

    ORGENTEC ANTI-JO-1 PIN IMMUNO ASSAY

    K Number: K954829 · Decision Apr 18, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    26
    Registration Numbers
    26
    Same Product Code
    111
    Applicant Total
    10
    Review Days
    181

    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
    ORGENTEC ANTI-JO-1 PIN IMMUNO ASSAY
    K Number
    K954829
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5100
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Orgentec
    Date Received
    October 20, 1995
    Decision Date
    April 18, 1996
    Product Code
    LJM
    Advisory Committee
    Immunology
    Review Advisory Committee
    IM
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LJM Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls

    Similar 510(k) Clearances

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

    EliA CENP Immunoassay, EliA U1RNP Immunoassay, EliA RNP70 Immunoassay

    FDA 510(k)
    FDA Class 2 ·Immunology

    ImmuLisa Enhanced Centromere Antibody ELISA

    FDA 510(k)
    FDA Class 2 ·Immunology

    ELIA SCL-70S IMMUNOASSAY

    FDA 510(k)
    FDA Class 2 ·Immunology

    QUANTA FLASH CENTROMERE

    FDA 510(k)
    FDA Class 2 ·Immunology

    GOLD STANDARD DIAGNOSTICS ANTI-NUCLEAR ANTIBODY (ANA) SCREEN ELISA TEST KIT

    FDA 510(k)
    FDA Class 2 ·Immunology

    ANA SCREEN ELISA (IGG)

    FDA 510(k)
    FDA Class 2 ·Immunology
    View all

    Other Clearances by Orgentec

    K Number Device Name
    K954831 ORGENTEC ANTI-RNP/SM PIN IMMUNO ASSAY
    K954830 ORGENTEC ANTI-SM(SMITH) PIN IMMUNO ASSAY
    K954832 ORGENTEC ANTI-SS-B(LA) PIN IMMUNO ASSAY
    K954814 ORGENTEC ANTI-SCL 70 PIN IMMUNO ASSAY
    K954815 ORGENTEC ANTI-SS-A(RO) PIN IMMUNO ASSAY
    K960274 ORGENTEC MICRO-ALBUMIN PIN EIA ASSAY
    K955134 ORGENTEC ENASCREEN ELISA ASSAY
    K955133 ORGENTEC ENASCREEN PIN IMMUNO ASSAY
    K953671 ORGEN TEC ANTI-DSDNA ELISA ASSAY