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

    HEMOCHRON KAOLIN-ACTIVATED HEPARIN AND PROTAMINE DOSING ASSAYS

    K Number: K010193 · Decision Jun 6, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    45
    Applicant Total
    47
    Review Days
    135

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    Basic Information

    Device Name
    HEMOCHRON KAOLIN-ACTIVATED HEPARIN AND PROTAMINE DOSING ASSAYS
    K Number
    K010193
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.7525
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    International Technidyne Corp.
    Date Received
    January 22, 2001
    Decision Date
    June 6, 2001
    Product Code
    KFF
    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
    KFF Assay, Heparin

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    Other Clearances by International Technidyne Corp.

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    K050016 HEMOCHRON SIGNATURE ELITE
    K030818 HEMOCHRON RESPONSE/SYSTEM
    K023561 ITC HGB PRO PROFESSIONAL HEMOGLOBIN TESTING SYSTEM
    K020798 HEMOCHRON JR. SIGNATURE +
    K010599 PROTIME MICROCOAGULATION SYSTEM / PROTIME 3 CUVETTE
    K983475 HEMOCHRON RESPONSE
    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. →