BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇮🇱 Israel

    IPAZYME(TM) CHLAMYDIA TRUE IGM(TM)

    K Number: K901975 · Decision Mar 8, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    7
    Applicant Total
    5
    Review Days
    311

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    Basic Information

    Device Name
    IPAZYME(TM) CHLAMYDIA TRUE IGM(TM)
    K Number
    K901975
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.3120
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Savyon Diagnostics , Ltd.
    Date Received
    May 1, 1990
    Decision Date
    March 8, 1991
    Product Code
    LKH
    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
    LKH Antisera, Immunoperoxidase, Chlamydia Spp.

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