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

    SERAQUEST ANTI-SSB

    K Number: K980639 · Decision Jun 15, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    25
    Registration Numbers
    25
    Same Product Code
    179
    Applicant Total
    25
    Review Days
    116

    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
    SERAQUEST ANTI-SSB
    K Number
    K980639
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5100
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Quest Intl., Inc.
    Date Received
    February 19, 1998
    Decision Date
    June 15, 1998
    Product Code
    LLL
    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
    LLL Extractable Antinuclear Antibody, Antigen And Control

    Similar 510(k) Clearances

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

    Alegria Flash CTD Screen

    FDA 510(k)
    FDA Class 2 ·Immunology

    Alegria Flash ENA Screen

    FDA 510(k)
    FDA Class 2 ·Immunology

    Aptiva CTD Essential Reagent

    FDA 510(k)
    FDA Class 2 ·Immunology

    EliA SymphonyS Immunoassay

    FDA 510(k)
    FDA Class 2 ·Immunology

    QUANTA Flash HMGCR Reagents

    FDA 510(k)
    FDA Class 2 ·Immunology

    QUANTA Flash Scl-70, QUANTA Flash Scl-70 Calibrators, QUANTA Flash Scl-70 Controls

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

    Other Clearances by Quest Intl., Inc.

    K Number Device Name
    K091260 SERAQUEST EBV EA-D IGG TEST
    K033915 MODIFICATION TO SERAQUEST EB VCA IGG
    K033780 MODIFICATION TO SERAQUEST VCA IGM
    K023593 SERAQUEST ANTI-THYROID PEROXIDASE (TPO)
    K023592 SERAQUEST ANTI-THYROGLOBULIN
    K003069 ANTI-CARDIOLIPIN, MULTIPLE AUTOANTIBODIES IMMUNOLOGICAL TEST SYSTEM
    K991975 SERAQUEST EB NA IGG
    K990410 SERAQUEST EB VCA IGG
    K990977 SERAQUEST EB VAC IGM
    K982485 SERAQUEST CMV IGM
    Search all 25 clearances from Quest Intl., Inc. →