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

    IL TEST PT FIBRINOGEN HS

    K Number: K923921 · Decision Oct 26, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    12
    Applicant Total
    321
    Review Days
    82

    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
    IL TEST PT FIBRINOGEN HS
    K Number
    K923921
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.7340
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Instrumentation Laboratory CO
    Date Received
    August 5, 1992
    Decision Date
    October 26, 1992
    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 Instrumentation Laboratory CO

    K Number Device Name
    K221359 ACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM, HemosIL CL Anti-ß2 Glycoprotein-I IgM
    K223187 HemosIL Liquid Anti-Xa
    K223090 GEM Premier ChemSTAT
    K223402 HemosIL von Willebrand Factor Antigen
    K213464 HemosIL Liquid Anti-Xa
    K213426 HemosIL ReadiPlasTin
    K203790 GEM Premier 5000
    DEN190032 HemosIL Liquid Anti-Xa
    K200033 HemosIL von Willebrand Factor Antigen
    K183549 GEM Premier ChemSTAT
    Search all 321 clearances from Instrumentation Laboratory CO →