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

    GUINEA PIG WHOLE SERUM

    K Number: K780009 · Decision Jan 20, 1978
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    44
    Applicant Total
    9
    Review Days
    17

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    Basic Information

    Device Name
    GUINEA PIG WHOLE SERUM
    K Number
    K780009
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    864.2800
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Northeast Biomedical Labs., Inc.
    Date Received
    January 3, 1978
    Decision Date
    January 20, 1978
    Product Code
    KIS
    Advisory Committee
    Hematology
    Review Advisory Committee
    PA
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    KIS Sera, Animal And Human

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    Other Clearances by Northeast Biomedical Labs., Inc.

    K Number Device Name
    K780696 GOAT ANTIINFLUENZA ANTISERA AUSSR
    K780697 GOAT ANTI-INFLUENZA ANTISERA ATEXAS
    K780007 GOAT ANTI-INFLUENZA ANTISERA
    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