BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    P.I.V. COMPLEMENT-FIXATION (C.F.) ANTIGEN

    K Number: K905385 · Decision Mar 21, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    10
    Applicant Total
    5
    Review Days
    111

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    Basic Information

    Device Name
    P.I.V. COMPLEMENT-FIXATION (C.F.) ANTIGEN
    K Number
    K905385
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.3400
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Virion (U.S.), Inc.
    Date Received
    November 30, 1990
    Decision Date
    March 21, 1991
    Product Code
    GQS
    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
    GQS Antigens, Cf (Including Cf Control), Parainfluenza Virus 1-4

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    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
    K864981 TOXOPLASMA GONDII