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

    RUBELLA VIRUS ANTIGENS & CONTROLS

    K Number: K802937 · Decision Dec 31, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    4
    Applicant Total
    28
    Review Days
    42

    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
    RUBELLA VIRUS ANTIGENS & CONTROLS
    K Number
    K802937
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3510
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Orion Diagnostica, Inc.
    Date Received
    November 19, 1980
    Decision Date
    December 31, 1980
    Product Code
    GON
    Advisory Committee
    Microbiology
    Review Advisory Committee
    MI
    Third Party
    N

    Classifications

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

    Product Code Device Name
    GON Antigen, Cf (Including Cf Control), Rubella

    Similar 510(k) Clearances

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

    RUBELLA ANTIGEN AND CONTROL ANTIGEN

    FDA 510(k)
    FDA Class 2 ·Microbiology

    MICROTRAK HSV 1/HSV 2 CULTURE IDENTI./TYPING TEST

    FDA 510(k)
    FDA Class 2 ·Microbiology

    HERPES SIMPLEX TYPE I

    FDA 510(k)
    FDA Class 2 ·Microbiology

    RUBELISA TEST KIT

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

    Other Clearances by Orion Diagnostica, Inc.

    K Number Device Name
    K942286 DIARLEX ROTA-ADENO
    K914892 SALIVA-STIM
    K904655 PYLORISET
    K884074 IMMUNOCHEMICAL DETERMINATION OF IMMUNOGLOBULIN G
    K884147 IMMUNOCHEMICAL DETERMINATION OF IMMUNOGLOBULIN M
    K884075 IMMUNOCHEMICAL DETERMINATION OF TRANSFERRIN
    K884040 IMMUNOCHEMICAL DETERMINATION OF IMMUNOGLOBULIN A
    K864645 ADENOLEX (R) LATEX AGGLUTINATION TEST
    K871196 RHEUMA-CHECK ENZYME IMMUNOASSAY TEST
    K862475 RESPIRASTICK ENZYME IMMUNOASSAY TEST
    Search all 28 clearances from Orion Diagnostica, Inc. →