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

    HEMOTEC ACT I SYSTEM

    K Number: K843459 · Decision Dec 12, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    23
    Applicant Total
    15
    Review Days
    98

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    Basic Information

    Device Name
    HEMOTEC ACT I SYSTEM
    K Number
    K843459
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.7140
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Hemotec, Inc.
    Date Received
    September 5, 1984
    Decision Date
    December 12, 1984
    Product Code
    JBP
    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
    JBP Activated Whole Blood Clotting Time

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    Other Clearances by Hemotec, Inc.

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    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
    Search all 15 clearances from Hemotec, Inc. →