CATALOG NO. J-ACT+ & QC-ACT+

K941007 · International Technidyne Corp. · JBP · Jun 30, 1994 · Hematology

Device Facts

Record IDK941007
Device NameCATALOG NO. J-ACT+ & QC-ACT+
ApplicantInternational Technidyne Corp.
Product CodeJBP · Hematology
Decision DateJun 30, 1994
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 864.7140
Device ClassClass 2

Regulatory Classification

Identification

An activated whole blood clotting time tests is a device, used to monitor heparin therapy for the treatment of venous thrombosis or pulmonary embolism by measuring the coagulation time of whole blood.

Innolitics

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