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

    HEMOCHRON RESPONSE

    K Number: K983475 · Decision May 3, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    13
    Applicant Total
    47
    Review Days
    213

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    Basic Information

    Device Name
    HEMOCHRON RESPONSE
    K Number
    K983475
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.5400
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    International Technidyne Corp.
    Date Received
    October 2, 1998
    Decision Date
    May 3, 1999
    Product Code
    KQG
    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
    KQG Instrument, Coagulation

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    Other Clearances by International Technidyne Corp.

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    K023561 ITC HGB PRO PROFESSIONAL HEMOGLOBIN TESTING SYSTEM
    K020798 HEMOCHRON JR. SIGNATURE +
    K010599 PROTIME MICROCOAGULATION SYSTEM / PROTIME 3 CUVETTE
    K010193 HEMOCHRON KAOLIN-ACTIVATED HEPARIN AND PROTAMINE DOSING ASSAYS
    K990449 HEMOCHRON ELECTRONIC SYSTEM VERIFICATION TUBE
    K972866 HEMOCHRON JR. MIOCROCOAGULATION CITRATED PT
    K974799 HEMOCHRON JR GENERATION II, HEMOCHRON JR SIGNATURE
    Search all 47 clearances from International Technidyne Corp. →