BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    HERPES HOMINUS I-COMPLE FIX ANTIGEN & NEGATIVE CLT

    K Number: K852931 · Decision Nov 12, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    15
    Applicant Total
    7
    Review Days
    126

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    Basic Information

    Device Name
    HERPES HOMINUS I-COMPLE FIX ANTIGEN & NEGATIVE CLT
    K Number
    K852931
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3305
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Microbix Biosystems, Inc.
    Date Received
    July 9, 1985
    Decision Date
    November 12, 1985
    Product Code
    GQO
    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
    GQO Antisera, Cf, Herpesvirus Hominis 1,2

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    Other Clearances by Microbix Biosystems, Inc.

    K Number Device Name
    K894261 TOXOPLASMA GONDII-CF ANTIGEN AND CONTROL ANTIGEN
    K894262 RUBELLA ANTIGEN AND CONTROL ANTIGEN
    K852932 MEASLES-COMPLEMENT FIX ANTIGEN & NEGATIVE CLT
    K852930 VARICELLA-ZOSTER-COMPLE FIX ANTIGEN AND NEG CONTRO
    K852929 CMV-COMPLEMENT FIXATION ANTIGEN AND NEGATIVE CONTR
    K852933 MYCOPLASMA SPP SEROLOGICAL REAGENTS