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

    BOTTLE, BLOOD CULTURE, BI-PHASIC

    K Number: K770683 · Decision Apr 26, 1977
    View on FDA
    Classifications
    1
    FEI Numbers
    25
    Registration Numbers
    25
    Same Product Code
    42
    Applicant Total
    67
    Review Days
    14

    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
    BOTTLE, BLOOD CULTURE, BI-PHASIC
    K Number
    K770683
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.2900
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Gibco Laboratories Life Technologies, Inc.
    Date Received
    April 12, 1977
    Decision Date
    April 26, 1977
    Product Code
    JTW
    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
    JTW System, Transport, Aerobic

    Similar 510(k) Clearances

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

    COPAN MSWAB COLLECTION, TRANSPORT AND PRESERVATION SYSTEM

    FDA 510(k)
    FDA Class 1 ·Microbiology

    COPAN LIQUID AMIES ELUTION SWAB (ESWAB) COLLECTION AND TRANSPORT SYSTEM

    FDA 510(k)
    FDA Class 1 ·Microbiology

    GEN-PROBE APTIMA COMBO 2 ASSAY

    FDA 510(k)
    FDA Class 1 ·Microbiology

    URINE COLLECTION, PRESERVATION AND TRANSPORT SYSTEM

    FDA 510(k)
    FDA Class 1 ·Microbiology

    COPAN EASY-SWAB COLLECTION AND TRANSPORT SYSTEM

    FDA 510(k)
    FDA Class 1 ·Microbiology

    SENSITITRE 18-24 HR SUSCEPTIBILITY PLATES(ADDITION OF MEROPENEM)

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

    Other Clearances by Gibco Laboratories Life Technologies, Inc.

    K Number Device Name
    K871855 SORBITOL MACCONKEY (SMAC) AGAR, DRI & PRE-FORM
    K871541 MARTIN-LEWIS AGAR W/REDUCED VANCOMYCIN C0226
    K870134 MCBRIDE LISTERIA AGAR W/CYCLOHEXIMIDE, DRI & PRE
    K864755 PSEUDOMONAS CEPACIA SELECTIVE AGAR, DRI & PRE-FORM
    K864014 LOMBARD DOWELL AGAR BASE
    K863821 MUELLER HINTON AGAR W/4%NACL AND OXACILLIN
    K863820 DRI-FORM: GBNA LISTERIA MEDIUM NO. M22300
    K863289 CDC ANAEROBIC AGAR W/SHEEP BLOOD, KANA-&VANCOMYCIN
    K862425 MACCONKEY AGAR W/MUG, DRI-FORM AND PRE-FORM
    K861058 SENSITITRE AUTO ID PLATE, AP70
    Search all 67 clearances from Gibco Laboratories Life Technologies, Inc. →