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

    MYCOPLASMA PNEUMONIAE ANTIBODY EIA TEST SYSTEM

    K Number: K920212 · Decision Aug 20, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    14
    Registration Numbers
    14
    Same Product Code
    12
    Applicant Total
    5
    Review Days
    217

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    Basic Information

    Device Name
    MYCOPLASMA PNEUMONIAE ANTIBODY EIA TEST SYSTEM
    K Number
    K920212
    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 16, 1992
    Decision Date
    August 20, 1992
    Product Code
    LJZ
    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
    LJZ Enzyme Linked Immunoabsorbent Assay, Mycoplasma Spp.

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    Other Clearances by Shared Systems, Inc.

    K Number Device Name
    K973457 CHROMALEX E. COLI 0157 LATEX TEST SYSTEM, PROD. NO. 800
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