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

    FIBRINOGEN DETERMINATION KIT

    K Number: K913061 · Decision Oct 9, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    12
    Applicant Total
    164
    Review Days
    91

    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
    FIBRINOGEN DETERMINATION KIT
    K Number
    K913061
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.7340
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sigma Diagnostics, Inc.
    Date Received
    July 10, 1991
    Decision Date
    October 9, 1991
    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

    Similar 510(k) Clearances

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

    Diazyme Fibrinogen Assay, Diazyme Fibrinogen Calibrator Set, Diazyme Fibrinogen Control Set

    FDA 510(k)
    FDA Class 2 ·Hematology

    FIBROTEK FIB

    FDA 510(k)
    FDA Class 2 ·Hematology

    K-ASSAY FIBRINOGEN

    FDA 510(k)
    FDA Class 2 ·Hematology

    QUANTITATIVE FIBRINOGEN ASSAY

    FDA 510(k)
    FDA Class 2 ·Hematology

    ENZIP IMMUNOTURBIDMETRIC FIBRINOGEN ASSAY KIT

    FDA 510(k)
    FDA Class 2 ·Hematology

    BIOMERIEUX HEMOLAB FIBRINOMAT

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

    Other Clearances by Sigma Diagnostics, Inc.

    K Number Device Name
    K021162 AMAX DENSITY COAGULATION ANALYZER, AMAX DENSTINY COAGULATION ANALYZER-EU, AMAX DESTINY COAGULATION ANALYZER-REFURBISHED
    K020109 SIGMA DIAGNOSTICS ACCUCLOT LA CONTROL
    K013549 SIGMA DIAGNOSTICS AUTO D-DIMER CALIBRATOR, MODEL A7971
    K013544 SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 2, MODEL A8096
    K013545 SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 3, MODEL A8221
    K012410 INFINITY HBA KIT, MODELS 537-A, 537-B
    K010652 SIGMA DIAGNOSTICS SIGMA-CAL, MODEL S2936
    K010158 THROMBOMAX-HS WITH CALCIUM, MODEL T6540
    K003267 SIGMA DIAGNOSTICS AUTO D-DIMER, MODEL CRS126-A
    K003329 SIGMA DIANOSTICS AUTO D-DIMER CONTROL LEVEL 2, MODEL A5217
    Search all 164 clearances from Sigma Diagnostics, Inc. →