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

    SENSITITRE SUSCEPTIBILITY PLATES

    K Number: K860753 · Decision May 6, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    440
    Applicant Total
    67
    Review Days
    68

    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
    SENSITITRE SUSCEPTIBILITY PLATES
    K Number
    K860753
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.1640
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Gibco Laboratories Life Technologies, Inc.
    Date Received
    February 27, 1986
    Decision Date
    May 6, 1986
    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 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. →