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

    SUPPLEMENT TO ANAEROBIC MIC PANEL

    K Number: K896332 · Decision Feb 5, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    440
    Applicant Total
    12
    Review Days
    95

    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
    SUPPLEMENT TO ANAEROBIC MIC PANEL
    K Number
    K896332
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.1640
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Microtech Medical Systems, Inc.
    Date Received
    November 2, 1989
    Decision Date
    February 5, 1990
    Product Code
    JWY
    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
    JWY Manual Antimicrobial Susceptibility Test Systems

    Similar 510(k) Clearances

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

    ETEST Gepotidacin (GEP) (0.016-256 µg/mL)

    FDA 510(k)
    FDA Class 2 ·Microbiology

    MTS Gepotidacin 0.016-256 µg/mL

    FDA 510(k)
    FDA Class 2 ·Microbiology

    MTS Aztreonam-Avibactam 0.016/4 - 256/4 µg/mL

    FDA 510(k)
    FDA Class 2 ·Microbiology

    The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Colistin in the dilution range of 0.12-16 ug/mL

    FDA 510(k)
    FDA Class 2 ·Microbiology

    The Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System with Aztreonam/avibactam in the dilution range of 0.008/4 - 64/4 ug/mL

    FDA 510(k)
    FDA Class 2 ·Microbiology

    The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Amikacin in the dilution range of 0.25-256 ug/mL

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

    Other Clearances by Microtech Medical Systems, Inc.

    K Number Device Name
    K935485 FAS FASTIDIOUS MIC PANEL
    K901598 FASTIDIOUS MIC PANEL
    K884831 ANAEROBIC MIC PANEL
    K863847 MIC - CONCEPT(TM) RX-2
    K861774 QUADRA-TITER (TM) I.D. (MODIFICATION)
    K860208 QUADRA-TITER I.D.
    K852613 MIC-CONCEPT SYSTEM
    K853745 MIC-CONCEPT VIEWBOX
    K850725 QUADRA TITER MICRO PLATES
    K851020 MIC-CONCEPT INOCULATOR
    Search all 12 clearances from Microtech Medical Systems, Inc. →