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

    TOXOPLASMA GONDII (TOXO) IGM ENZYME-LINKED IMMUNO

    K Number: K920702 · Decision Jul 8, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    32
    Registration Numbers
    32
    Same Product Code
    105
    Applicant Total
    7
    Review Days
    141

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    Basic Information

    Device Name
    TOXOPLASMA GONDII (TOXO) IGM ENZYME-LINKED IMMUNO
    K Number
    K920702
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3780
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Pharmacia Diagnostics, Inc.
    Date Received
    February 18, 1992
    Decision Date
    July 8, 1992
    Product Code
    LGD
    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
    LGD Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii

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    Other Clearances by Pharmacia Diagnostics, Inc.

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