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

    DIAMEDIX IS-ANA ELISA SCREEN TEST SYSTEM

    K Number: K993294 · Decision Oct 25, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18
    Same Product Code
    49
    Applicant Total
    68
    Review Days
    24

    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
    DIAMEDIX IS-ANA ELISA SCREEN TEST SYSTEM
    K Number
    K993294
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5100
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Diamedix Corp.
    Date Received
    October 1, 1999
    Decision Date
    October 25, 1999
    Product Code
    LKJ
    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
    LKJ Antinuclear Antibody, Antigen, Control

    Similar 510(k) Clearances

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

    EliA Ro52, EliA Ro60

    FDA 510(k)
    FDA Class 2 ·Immunology

    ANA-SCREEN WITH MDSS

    FDA 510(k)
    FDA Class 2 ·Immunology

    ELIA CENP IMMUNOASSAY, ELIA U1RNP IMMUNOASSAY, ELIA SM IMMUNOASSAY, ELIA RO IMMUNOASSAY

    FDA 510(k)
    FDA Class 2 ·Immunology

    AESKULISA ANA HEP-2, REF 30-7115US

    FDA 510(k)
    FDA Class 2 ·Immunology

    BIOPLEX 200 ANA SCREEN ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM, MODEL BIOPLEX 2200

    FDA 510(k)
    FDA Class 2 ·Immunology

    ATHENA MULTI-LYTE ANA-II TEST SYSTEM

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

    Other Clearances by Diamedix Corp.

    K Number Device Name
    K093101 MAGO 4S
    K021394 DIAMEDIX IS-RHEUMATOID FACTOR TEST SYSTEM
    K013956 DIAMEDIX IS-ANTI-B2 GLYCOPROTEIN I SCREEN
    K013628 DIAMEDIX IS-ANTI-B2 GLYCOPROTEIN I IGG/IGM TEST SYSTEM
    K012450 DIAMEDIX IS-ANTI-CARDIOLIPIN IGA TEST SYSTEM
    K012449 DIAMEDIX IS-ANTI-CARDIOLIPIN IGG/IGM TEST SYSTEM
    K012795 DIAMEDIX IS-ANTI-GLIADIN IGG TEST SYSTEM
    K012797 DIAMEDIX IS-ANTI-GLIADIN IGA TEST SYSTEM
    K012053 DIAMEDIX IS-ANTI-CARDIOLIPIN SCREEN TEST SYSTEM
    K002262 DIAMEDIX IS-HSV 1&2 IGM TEST SYSTEM
    Search all 68 clearances from Diamedix Corp. →