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

    ORTHO *APO A-1 ELISA TEST SYSTEM

    K Number: K895160 · Decision Oct 6, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    4
    Applicant Total
    2
    Review Days
    44

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    Basic Information

    Device Name
    ORTHO *APO A-1 ELISA TEST SYSTEM
    K Number
    K895160
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.5590
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Applicant
    Medical Marketing Consultants, Inc.
    Date Received
    August 23, 1989
    Decision Date
    October 6, 1989
    Product Code
    DEL
    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
    DEL Lipoprotein X, Antigen, Antiserum, Control

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    Other Clearances by Medical Marketing Consultants, Inc.

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