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

    BOVINE ALBUMIN 22% & 30% SOLUTIONS

    K Number: K800189 · Decision Feb 13, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    12
    Applicant Total
    2
    Review Days
    15

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    Basic Information

    Device Name
    BOVINE ALBUMIN 22% & 30% SOLUTIONS
    K Number
    K800189
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.9600
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Gotham Biologics, Inc.
    Date Received
    January 29, 1980
    Decision Date
    February 13, 1980
    Product Code
    KSG
    Advisory Committee
    Hematology
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

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

    Product Code Device Name
    KSG Media, Potentiating For In Vitro Diagnostic Use

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