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

    DIRECTDRAW SUPERSERUM

    K Number: K921778 · Decision May 28, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    36
    Registration Numbers
    36
    Same Product Code
    38
    Applicant Total
    47
    Review Days
    44

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    Basic Information

    Device Name
    DIRECTDRAW SUPERSERUM
    K Number
    K921778
    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
    April 14, 1992
    Decision Date
    May 28, 1992
    Product Code
    GIM
    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
    GIM Tubes, Vacuum Sample, With Anticoagulant

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    Other Clearances by International Technidyne Corp.

    K Number Device Name
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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
    Search all 47 clearances from International Technidyne Corp. →