BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    ANTI-GM & ANTI-KM TYPING SERUMS

    K Number: K812076 · Decision Aug 12, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    0
    Applicant Total
    2
    Review Days
    21

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    ANTI-GM & ANTI-KM TYPING SERUMS
    K Number
    K812076
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5510
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Applicant
    Biotest-Serum-Institut
    Date Received
    July 22, 1981
    Decision Date
    August 12, 1981
    Product Code
    DGH
    Advisory Committee
    Immunology
    Review Advisory Committee
    IM
    Third Party
    N

    Classifications

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

    Product Code Device Name
    DGH Igd, Peroxidase, Antigen, Antiserum, Control

    Other Clearances by Biotest-Serum-Institut

    K Number Device Name
    K770253 MICROFILTRATION SET MF10