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

    DIRECTDRAW SUPERSERUM-G DIRECTDRAW SUPERSERUM-MINI-G

    K Number: K941159 · Decision May 19, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    218
    Registration Numbers
    218
    Same Product Code
    235
    Applicant Total
    47
    Review Days
    69

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    Basic Information

    Device Name
    DIRECTDRAW SUPERSERUM-G DIRECTDRAW SUPERSERUM-MINI-G
    K Number
    K941159
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1675
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    International Technidyne Corp.
    Date Received
    March 11, 1994
    Decision Date
    May 19, 1994
    Product Code
    JKA
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    JKA Tubes, Vials, Systems, Serum Separators, Blood Collection

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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
    K010193 HEMOCHRON KAOLIN-ACTIVATED HEPARIN AND PROTAMINE DOSING ASSAYS
    K983475 HEMOCHRON RESPONSE
    K990449 HEMOCHRON ELECTRONIC SYSTEM VERIFICATION TUBE
    K972866 HEMOCHRON JR. MIOCROCOAGULATION CITRATED PT
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