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K Number
K062604
Device Name
RAPIDTEG TEG-ACT TEST
Manufacturer
HAEMOSCOPE CORP.
Date Cleared
2007-01-31

(152 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

The RapidTEG™ TEG®-ACT Test is a quantitative in vitro diagnostic test intended to monitor heparin anticoagulation in adult patients. It is intended for the use with the Thrombelastograph® (TEG®) Hemostasis System.

Device Description

Not Found

AI/ML Overview

The provided text is a 510(k) premarket notification letter from the FDA. It does not contain the detailed acceptance criteria or the study information requested. The letter only states that the device is substantially equivalent to legally marketed predicate devices.

Therefore, I cannot provide the requested information from the given input.

§ 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).