LogoFDA 510(k) Search
K Number
K960749
Device Name
HEMOCHRON JR. MICROCOAGULATION LOW RANGE ACT
Manufacturer
INTERNATIONAL TECHNIDYNE CORP.
Date Cleared
1996-08-12

(171 days)

Product Code
JBP
Regulation Number
864.7140
Type
Traditional
Panel
HE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

§ 864.7140 Activated whole blood clotting time tests.

(a)
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.(b)
Classification. Class II (performance standards).