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

    IMMUNOSCAN(TM) DIRECT STREPTOCOCCUS PNEUMONIAE

    K Number: K870029 · Decision Mar 25, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    8
    Applicant Total
    24
    Review Days
    79

    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
    IMMUNOSCAN(TM) DIRECT STREPTOCOCCUS PNEUMONIAE
    K Number
    K870029
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.3740
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    American Micro Scan
    Date Received
    January 5, 1987
    Decision Date
    March 25, 1987
    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

    LKB ULTROBACT (TM) PNEUMOCOCCUS KIT; 2321-110

    FDA 510(k)
    FDA Class 1 ·Microbiology

    VENTRESCREEN STREP A TEST

    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 American Micro Scan

    K Number Device Name
    K864662 CHLAMYDIAE FLUOR. AB TEST FOR DETECTION IN SMEARS
    K863776 MICRODILUTION MIC PANELS
    K864674 MICRODILUTION IDENTIFICATION PANELS
    K864389 CHLAMYDIAE FLOURESCENT MONOCLONAL ANTIBODY TEST
    K863038 GRAM POSITIVE FLUORESCENT IDENTIFICATION PANEL
    K862642 GRAM NEGATIVE FLUORESCENT IDENTIFICATION PANEL
    K862332 ANAEROBE RAPID CHROMOGENIC ID PANEL
    K862140 MICRODILUTION PANELS
    K861584 GRAM NEGATIVE COMBO PANEL TYPE 3
    K860575 YEAST IDENTIFICATION PANEL
    Search all 24 clearances from American Micro Scan →