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

    HERPES SIMPLEX VIRUS TYPING REAGENTS

    K Number: K830971 · Decision Jun 30, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    36
    Applicant Total
    15
    Review Days
    94

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    Basic Information

    Device Name
    HERPES SIMPLEX VIRUS TYPING REAGENTS
    K Number
    K830971
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3305
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Immulok, Inc.
    Date Received
    March 28, 1983
    Decision Date
    June 30, 1983
    Product Code
    GQL
    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
    GQL Antisera, Fluorescent, Herpesvirus Hominis 1,2

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    Other Clearances by Immulok, Inc.

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    K822607 ANTINUCLEAR ANTOBODY CELL SUBSTRATE
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