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

    ORTHO APO B ELISA TEST SYSTEM

    K Number: K895277 · Decision Sep 27, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    21
    Registration Numbers
    21
    Same Product Code
    49
    Applicant Total
    2
    Review Days
    35

    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
    ORTHO APO B ELISA TEST SYSTEM
    K Number
    K895277
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1475
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Medical Marketing Consultants, Inc.
    Date Received
    August 23, 1989
    Decision Date
    September 27, 1989
    Product Code
    MSJ
    Advisory Committee
    Clinical Chemistry
    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
    MSJ Apolipoproteins

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (MSJ), ordered by most recent decision date.

    DIAZYME APOLIPOPROTEIN A-1 ASSAY

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    DIAZYME APOLIPOPROTEIN B ASSAY, MODEL DZXXX-X; B CALIBRATOR, MODEL DZXXX

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    APOLIPOPROTEIN A1 AND APOLIPOPROTEIN B REAGENTS AND CALIBRATORS

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    DIMENSION VISTA APOA1 AND APOB FLEX REAGENT CARTRIDGES AND PROTEIN 1 CALIBRATOR AND CONTROL MEDIUM AND HIGH

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    8 ADDITIONAL ASSAYS FOR THE BAYER ADVIA 1650 CHEMISTRY SYSTEM

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    SYNCHRON LX SYSTEMS APOLIPOPROTEIN (APOA AND APOB) REAGENTS

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry
    View all

    Other Clearances by Medical Marketing Consultants, Inc.

    K Number Device Name
    K895160 ORTHO *APO A-1 ELISA TEST SYSTEM