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

    K-ASSAY FIBRINOGEN

    K Number: K993482 · Decision Dec 6, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    12
    Applicant Total
    43
    Review Days
    53

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    Basic Information

    Device Name
    K-ASSAY FIBRINOGEN
    K Number
    K993482
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.7340
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Kamiya Biomedical Co.
    Date Received
    October 14, 1999
    Decision Date
    December 6, 1999
    Product Code
    GIS
    Advisory Committee
    Hematology
    Review Advisory Committee
    HE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    GIS Test, Fibrinogen

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    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. →