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

    GOAT ANTIINFLUENZA ANTISERA AUSSR

    K Number: K780696 · Decision May 3, 1978
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    8
    Applicant Total
    9
    Review Days
    9

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    Basic Information

    Device Name
    GOAT ANTIINFLUENZA ANTISERA AUSSR
    K Number
    K780696
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.3330
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Northeast Biomedical Labs., Inc.
    Date Received
    April 24, 1978
    Decision Date
    May 3, 1978
    Product Code
    GNS
    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
    GNS Antisera, Hai, Influenza Virus A, B, C

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (GNS), ordered by most recent decision date.

    GOAT ANTI-INFLUENZA ANTISERA ATEXAS

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    INFLUENZA HI ANTISERUM A/TEXAS

    FDA 510(k)
    FDA Class 1 ·Microbiology

    INFLUENZA HI PRESERUM A/TEXAS

    FDA 510(k)
    FDA Class 1 ·Microbiology

    GOAT ANTI-INFLUENZA ANTISERA

    FDA 510(k)
    FDA Class 1 ·Microbiology
    View all

    Other Clearances by Northeast Biomedical Labs., Inc.

    K Number Device Name
    K780697 GOAT ANTI-INFLUENZA ANTISERA ATEXAS
    K780007 GOAT ANTI-INFLUENZA ANTISERA
    K780009 GUINEA PIG WHOLE SERUM
    K780005 GOAT ANTI-INFLUENZA ANTISERA
    K780010 GOAT ANTI-RUBELLA ANTISERA
    K780006 GOAT ANTI-INFLUENZA ANTISERA
    K780008 GOAT ANTI-INFLUENZA ANTISERA
    K780004 GOAT ANTI-INFLUENZA ANTISERA