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

    VARICELLA-ZOSTER-COMPLE FIX ANTIGEN AND NEG CONTRO

    K Number: K852930 · Decision Nov 12, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    10
    Applicant Total
    7
    Review Days
    126

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    Basic Information

    Device Name
    VARICELLA-ZOSTER-COMPLE FIX ANTIGEN AND NEG CONTRO
    K Number
    K852930
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3900
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Microbix Biosystems, Inc.
    Date Received
    July 9, 1985
    Decision Date
    November 12, 1985
    Product Code
    GQX
    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
    GQX Antiserum, Cf, Varicella-Zoster

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    K852931 HERPES HOMINUS I-COMPLE FIX ANTIGEN & NEGATIVE CLT
    K852929 CMV-COMPLEMENT FIXATION ANTIGEN AND NEGATIVE CONTR
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