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

    HEMOTEC HEPCON HMS COAGULATION SYSTEM & ACCESS.

    K Number: K894317 · Decision Sep 5, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    14
    Applicant Total
    15
    Review Days
    53

    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
    HEMOTEC HEPCON HMS COAGULATION SYSTEM & ACCESS.
    K Number
    K894317
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.5680
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Hemotec, Inc.
    Date Received
    July 14, 1989
    Decision Date
    September 5, 1989
    Product Code
    JOX
    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
    JOX Analyzer, Heparin, Automated

    Similar 510(k) Clearances

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

    HEMOSTASIS MANAGMENT SYSTEM PLUS (HMS-PLUS)

    FDA 510(k)
    FDA Class 2 ·Hematology

    HEPARIN DOSE RESPONSE CARTRIDGE

    FDA 510(k)
    FDA Class 2 ·Hematology

    HEMOSTASIS MANAGEMENT SYSTEM PLUS (HMS PLUS ), MODEL 305 XX

    FDA 510(k)
    FDA Class 2 ·Hematology

    HEPARIN DOSE RESPONSE CONTROLS, MODEL 306-20 POR

    FDA 510(k)
    FDA Class 2 ·Hematology

    HEPARIN DOSE RESPONSE CONTROLS, MODEL 306-20 POR

    FDA 510(k)
    FDA Class 2 ·Hematology

    HEPARIN DOSE RESPONSE CARTRIDGE, MODEL 304-20

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

    Other Clearances by Hemotec, Inc.

    K Number Device Name
    K902081 CLOTTRAC(TM) IBEX HEPARINASE HR ACT CART./CONTROL
    K894359 CLOTRAC CITRATED WHOLE BLOOD COAGULATION CONTROLS
    K894466 HEPCON(R) CV WHOLE BLOOD COAGULATION CONTROLS
    K884590 HEPCON/SYSTEM B-10 HEPARIN ASSAY/SCREEN/CARTRIDGES
    K875089 HEPCON SYSTEM B-10 ACTIVATED CLOT TIME & HEPARIN
    K880302 CALCIUM CHLORIDE SOLUTION 0.1M, IN HEPES BUFFER
    K854377 HEMOTEC CV WHOLE BLOOD COAGULATION CONTROLS
    K854376 HEMOTEC CITRATED WHOLE BLOOD COAGULATION CONTROLS
    K853789 ADDITIONAL HEMOTEC HEPCON/SYS B-10 COAGULATION CAR
    K843459 HEMOTEC ACT I SYSTEM
    Search all 15 clearances from Hemotec, Inc. →