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

    PARAINFLUENZA 1,2, & 3 ANTIGENS & CONTR

    K Number: K802935 · Decision Dec 31, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    10
    Applicant Total
    28
    Review Days
    42

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    Basic Information

    Device Name
    PARAINFLUENZA 1,2, & 3 ANTIGENS & CONTR
    K Number
    K802935
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.3400
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Orion Diagnostica, Inc.
    Date Received
    November 19, 1980
    Decision Date
    December 31, 1980
    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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