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

    API UNISCEPT MIC/TYPE 2 AND 3 AND MICRO MIC

    K Number: K923684 · Decision Dec 3, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    433
    Applicant Total
    57
    Review Days
    133

    Basic Information

    Device Name
    API UNISCEPT MIC/TYPE 2 AND 3 AND MICRO MIC
    K Number
    K923684
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.1640
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    ANALYTICAL PRODUCTS, INC.
    Date Received
    July 23, 1992
    Decision Date
    December 3, 1992
    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

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    Other Clearances by ANALYTICAL PRODUCTS, INC.

    K Number Device Name
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    K901390 DMAC INDOLE REAGENT
    K895796 API UNISCEPT KB
    K884510 MODIFICATION MICRO-MIC
    K884509 MODIFICATION MIC/API UNISCEPT(R)
    K880598 MODIFICATIONS TO API UNISCEPT (R) KB
    K874466 API UNISCEPT(R) MICRO-MIC(R) SYSTEM/UNISCEPT MIC
    K865062 ALADIN (TM)
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