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

    ENZYME LINKED IMMUNOABSORBENT ASSAY, TOXOPLASMA GONDII

    K Number: K952818 · Decision Nov 20, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    7
    Applicant Total
    12
    Review Days
    153

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    Basic Information

    Device Name
    ENZYME LINKED IMMUNOABSORBENT ASSAY, TOXOPLASMA GONDII
    K Number
    K952818
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3780
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Pyramid Biological Corp.
    Date Received
    June 20, 1995
    Decision Date
    November 20, 1995
    Product Code
    GMM
    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
    GMM Antigens, Iha, Toxoplasma Gondii

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