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

    AMIZYME-CMV KIT

    K Number: K842529 · Decision Dec 6, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    17
    Applicant Total
    32
    Review Days
    526

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    Basic Information

    Device Name
    AMIZYME-CMV KIT
    K Number
    K842529
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3175
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Amico Lab, Inc.
    Date Received
    June 28, 1984
    Decision Date
    December 6, 1985
    Product Code
    GQI
    Advisory Committee
    Microbiology
    Review Advisory Committee
    IM
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    GQI Antiserum, Cf, Cytomegalovirus

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    Other Clearances by Amico Lab, Inc.

    K Number Device Name
    K842662 ANTI-EPSTEIN-BARR VIRUS KIT
    K842530 AMIZYME-EBV TEST KIT
    K842663 ANTI-HERPES SIMPLEX VIRUS TYPE 1 OR 2
    K842531 AMIZYME-HSV TYPES 1 & 2 TEST KITS
    K842661 ANTI-CYTOMEGALOVIRUS KIT
    K842660 ANTI-SCHISTOSOMA SPECIES KIT
    K842658 ANTI-CHLAMYDIA TRACHOMATIS KIT
    K842525 AMIZYME-C TRACHOMATIS TEST KIT
    K842532 AMIZYME-ANA TEST KIT
    K842533 AMIZYME-ANDNA TEST KIT
    Search all 32 clearances from Amico Lab, Inc. →