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

    TOXOPLASMA GONDII-CF ANTIGEN AND CONTROL ANTIGEN

    K Number: K894261 · Decision Oct 16, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    2
    Applicant Total
    7
    Review Days
    117

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    Basic Information

    Device Name
    TOXOPLASMA GONDII-CF ANTIGEN AND CONTROL ANTIGEN
    K Number
    K894261
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3780
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Microbix Biosystems, Inc.
    Date Received
    June 21, 1989
    Decision Date
    October 16, 1989
    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.

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    K852931 HERPES HOMINUS I-COMPLE FIX ANTIGEN & NEGATIVE CLT
    K852929 CMV-COMPLEMENT FIXATION ANTIGEN AND NEGATIVE CONTR
    K852933 MYCOPLASMA SPP SEROLOGICAL REAGENTS