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

    RADIOMETRIC BLOOD CULTURE VIALS, AEROBE

    K Number: K842874 · Decision Sep 12, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    10
    Applicant Total
    24
    Review Days
    51

    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
    RADIOMETRIC BLOOD CULTURE VIALS, AEROBE
    K Number
    K842874
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.2560
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    American Micro Scan
    Date Received
    July 23, 1984
    Decision Date
    September 12, 1984
    Product Code
    JTA
    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
    JTA Monitor, Microbial Growth

    Similar 510(k) Clearances

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

    BACTEC FUNGAL MEDIUM

    FDA 510(k)
    FDA Class 1 ·Microbiology

    BACTEC NR-860

    FDA 510(k)
    FDA Class 1 ·Microbiology

    BACTEC(R) NR-660 HIGH PERFORMANCE SYSTEM

    FDA 510(k)
    FDA Class 1 ·Microbiology

    BACTEC NR-730 BACTERIAL DETECTION SYSTEM

    FDA 510(k)
    FDA Class 1 ·Microbiology

    BECTEC NR-660 BACTERIAL DETECT SYS

    FDA 510(k)
    FDA Class 1 ·Microbiology

    BAC-T-SCREEN

    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
    K870029 IMMUNOSCAN(TM) DIRECT STREPTOCOCCUS PNEUMONIAE
    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
    Search all 24 clearances from American Micro Scan →