BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    HISTOSET IMMUNOPEROXIDASE TISSURE KIT

    K Number: K820390 · Decision Apr 14, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    7
    Applicant Total
    15
    Review Days
    63

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    Basic Information

    Device Name
    HISTOSET IMMUNOPEROXIDASE TISSURE KIT
    K Number
    K820390
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.3120
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Immulok, Inc.
    Date Received
    February 10, 1982
    Decision Date
    April 14, 1982
    Product Code
    LKH
    Advisory Committee
    Microbiology
    Review Advisory Committee
    CH
    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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