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

    BACTON TM, BASIC TM, APO A-I REAGENT

    K Number: K893885 · Decision Jun 21, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    4
    Applicant Total
    41
    Review Days
    22

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    Basic Information

    Device Name
    BACTON TM, BASIC TM, APO A-I REAGENT
    K Number
    K893885
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.5590
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Applicant
    Catachem, Inc.
    Date Received
    May 30, 1989
    Decision Date
    June 21, 1989
    Product Code
    DEL
    Advisory Committee
    Immunology
    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
    DEL Lipoprotein X, Antigen, Antiserum, Control

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