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

    HSV IGM TEST

    K Number: K830865 · Decision Jul 18, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    36
    Applicant Total
    57
    Review Days
    122

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    Basic Information

    Device Name
    HSV IGM TEST
    K Number
    K830865
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3305
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Gull Laboratories, Inc.
    Date Received
    March 18, 1983
    Decision Date
    July 18, 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 Gull Laboratories, Inc.

    K Number Device Name
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    K962343 TOXO IGG ELISA TEST
    K935730 EBNA IGG ELISA TEST
    K940093 EBV-EA(D) IGG ELISA TEST
    K941046 VZV IGG ELISA TEST
    K941198 EBV LGG ELISA TEST
    K932333 PROTECTORAL ULTRASONIC HANDPIECE PROCESSOR
    K941624 RUBELLA IGG ELISA TEST
    K922758 HSV-1 IGM ELISA TEST -- MODIFICATION
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