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

    API UNISCEPT(R) MICRO-MIC(R) SYSTEM/UNISCEPT MIC

    K Number: K874466 · Decision Dec 9, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    440
    Applicant Total
    57
    Review Days
    37

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    Basic Information

    Device Name
    API UNISCEPT(R) MICRO-MIC(R) SYSTEM/UNISCEPT MIC
    K Number
    K874466
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.1640
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Analytical Products, Inc.
    Date Received
    November 2, 1987
    Decision Date
    December 9, 1987
    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
    K924814 API 20E/UNISCEPT 20E
    K923684 API UNISCEPT MIC/TYPE 2 AND 3 AND MICRO MIC
    K922926 API UNISCEPT KB/TYPE 2 AND 3
    K901559 MODIFICATION TO API UNISCEPT 20GP
    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
    K865062 ALADIN (TM)
    Search all 57 clearances from Analytical Products, Inc. →