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

    VENTRESCREEN STREP A TEST

    K Number: K842239 · Decision Jul 2, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    8
    Applicant Total
    82
    Review Days
    27

    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
    VENTRESCREEN STREP A TEST
    K Number
    K842239
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.3740
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Ventrex Laboratories, Inc.
    Date Received
    June 5, 1984
    Decision Date
    July 2, 1984
    Product Code
    GWC
    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
    GWC Antisera, All Types, Streptococcus Pneumoniae

    Similar 510(k) Clearances

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

    BACTIGEN(R) MENINGITIDIS PANEL

    FDA 510(k)
    FDA Class 1 ·Microbiology

    BACTIGEN(R) S. PNEUMONIAE

    FDA 510(k)
    FDA Class 1 ·Microbiology

    IMMUNOSCAN(TM) DIRECT STREPTOCOCCUS PNEUMONIAE

    FDA 510(k)
    FDA Class 1 ·Microbiology

    LKB ULTROBACT (TM) PNEUMOCOCCUS KIT; 2321-110

    FDA 510(k)
    FDA Class 1 ·Microbiology

    WELLCOGEN S. PNEUMONIAE

    FDA 510(k)
    FDA Class 1 ·Microbiology

    BACTIGEN S. PNEUMONIAE

    FDA 510(k)
    FDA Class 1 ·Microbiology
    View all

    Other Clearances by Ventrex Laboratories, Inc.

    K Number Device Name
    K914554 SPECIFIC IGE EIA-TURBO ASSAY
    K913833 VENTREX ALLERGEN DISC
    K913434 VENTREX COATED TUBE INTACT PTH
    K905612 VENTREX COATED TUBE IGE RADIOIMMUNOASSAY
    K905636 VENTREX COATED TUBE IGE ENZYME IMMUNOASSAY
    K905247 SHBG IRMA KIT
    K904330 TURBO-RAST SPECIFIC IGE ASSAY
    K903000 TURBO-RAST SPECIFIC IGE ASSAY
    K897083 VENTRESIGN STREP A TEST
    K895648 COATED TUBE HIGH SENSITIVITY TSH 100 UIU/ML STAN.
    Search all 82 clearances from Ventrex Laboratories, Inc. →