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

    IMMUNODIFFUSION REAGENTS/SEROLOGICAL

    K Number: K802129 · Decision Sep 26, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    10
    Applicant Total
    5
    Review Days
    53

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    Basic Information

    Device Name
    IMMUNODIFFUSION REAGENTS/SEROLOGICAL
    K Number
    K802129
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3135
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Nolan Biological Laboratories, Inc.
    Date Received
    August 4, 1980
    Decision Date
    September 26, 1980
    Product Code
    GMI
    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
    GMI Antigen, Cf And / Or Id, Coccidioides Immitis

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    Other Clearances by Nolan Biological Laboratories, Inc.

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    K812741 REAGENTS FOR SERODIAGNOSIS OF CANDIDOSIS
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    K802130 IMMUNO. IDENTIFICATION OF H. CAPSULATUM
    K802128 IMMUNODIFFUSSION REAGENTS/SEROLOGICAL