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

    MYCOPLASMA PNEUMONIAE ANTIBODY LATEX AGGLUTINATION TEST SYSTEM

    K Number: K950073 · Decision Oct 17, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    5
    Applicant Total
    5
    Review Days
    281

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    Basic Information

    Device Name
    MYCOPLASMA PNEUMONIAE ANTIBODY LATEX AGGLUTINATION TEST SYSTEM
    K Number
    K950073
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.3375
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Shared Systems, Inc.
    Date Received
    January 9, 1995
    Decision Date
    October 17, 1995
    Product Code
    GSA
    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
    GSA Antisera, All Mycoplasma Spp.

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