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

    HISTOSET IMMUNOPEROFIDASE TISSUE

    K Number: K821411 · Decision Jun 25, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    36
    Applicant Total
    15
    Review Days
    44

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    Basic Information

    Device Name
    HISTOSET IMMUNOPEROFIDASE TISSUE
    K Number
    K821411
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3305
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Immulok, Inc.
    Date Received
    May 12, 1982
    Decision Date
    June 25, 1982
    Product Code
    GQL
    Advisory Committee
    Microbiology
    Review Advisory Committee
    PA
    Third Party
    N

    Classifications

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

    Product Code Device Name
    GQL Antisera, Fluorescent, Herpesvirus Hominis 1,2

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    Other Clearances by Immulok, Inc.

    K Number Device Name
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    K823304 RIASET PROLACTIN RIA KIT
    K822785 FLUOROSET IMMUNOFLUORESCENT ANTIBODY
    K823055 FLOUROSET IMMUNOFLUORESCENT ANTIBODY
    K822606 CYTOMEGALOVIRUS ANTOBODY IGG
    K822605 TOXOPLASMA GONDII ANTIBODY IGG
    K822607 ANTINUCLEAR ANTOBODY CELL SUBSTRATE
    K821567 IMMULOK CULTURESET
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