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

    TOXOPLASMA GONDII

    K Number: K864981 · Decision Oct 30, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    2
    Applicant Total
    5
    Review Days
    312

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    Basic Information

    Device Name
    TOXOPLASMA GONDII
    K Number
    K864981
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3780
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Virion (U.S.), Inc.
    Date Received
    December 22, 1986
    Decision Date
    October 30, 1987
    Product Code
    GMN
    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
    GMN Antigens, Cf, Toxoplasma Gondii

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (GMN), ordered by most recent decision date.

    TOXOPLASMA GONDII-CF ANTIGEN AND CONTROL ANTIGEN

    FDA 510(k)
    FDA Class 2 ·Microbiology

    AGGLUTINOTEST-TOXOPLASMOSIS

    FDA 510(k)
    FDA Class 2 ·Microbiology
    View all

    Other Clearances by Virion (U.S.), Inc.

    K Number Device Name
    K933251 EPSTEIN-BARR VIRUS COMBI TEST, EBV COMBI TEST
    K921618 COXSACKIE VIRUS B1-B6 CF ANTIGENS
    K905306 MUMPS COMPLEMENT-FIXATION (C.F.) ANTIGEN
    K905385 P.I.V. COMPLEMENT-FIXATION (C.F.) ANTIGEN