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

    K-ASSAY APO AI

    K Number: K993345 · Decision Oct 25, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    16
    Applicant Total
    43
    Review Days
    20

    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
    K-ASSAY APO AI
    K Number
    K993345
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5580
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Kamiya Biomedical Co.
    Date Received
    October 5, 1999
    Decision Date
    October 25, 1999
    Product Code
    DER
    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
    DER Alpha-1-Lipoprotein, Antigen, Antiserum, Control

    Similar 510(k) Clearances

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

    TINA-QUANT APOLIPOPROTEIN VER.2

    FDA 510(k)
    FDA Class 2 ·Immunology

    BAYER ADVIA IMS SYSTEM; 200 + 3

    FDA 510(k)
    FDA Class 2 ·Immunology

    K-ASSAY APO B

    FDA 510(k)
    FDA Class 2 ·Immunology

    INTEGRA REAGENT CASSETTE FOR APOLIPOPROTEIN A-1

    FDA 510(k)
    FDA Class 2 ·Immunology

    APOLIPOPROTEIN A1

    FDA 510(k)
    FDA Class 2 ·Immunology

    N-ASSAY TIA APO B TEST KIT

    FDA 510(k)
    FDA Class 2 ·Immunology
    View all

    Other Clearances by Kamiya Biomedical Co.

    K Number Device Name
    K093137 K-ASSAY CYSTATIN C REAGENT, CALIBRATOR AND CONTROL
    K091486 K-ASSAY MICROALBUMIN AND K-ASSAY MICROALBUMIN CALIBRATOR
    K050944 K-ASSAY FERRITIN (2) & FERRITIN CALIBRATOR SET
    K042241 K-ASSAY TOTAL IGE, K-ASSAY IGE CALIBRATOR SET, MODELS KAI-092/KAI-093C
    K030687 K-ASSAY D-DIMER, K-ASSAY D-DIMER CALIBRATOR, MODELS KAI-090; KAJ-091C
    K023828 K-ASSAY C-REACTIVE PROTEIN (3), K-ASSAY CRP MULTI-CALIBRATOR D, K-ASSAY CRP MULTI-CALIBRATOR E, K-ASSAY CRP MULTI-CALIBR
    K023853 K-ASSAY LP(A) CONTROLS
    K022486 K-ASSAY HS-CRP CONTROLS
    K021660 K-ASSAY LP(A) ASSAY
    K014293 K-ASSAY FERRITIN, K-ASSAY FERRITIN CALIBRATOR SET
    Search all 43 clearances from Kamiya Biomedical Co. →