K993519 - RAPIDPOINT ACCENT, MODEL 2000, RAPIDPOINT COAG HEPARIN TITRATION TEST, RAPIDPOINT COAG PROTAMINE RESPONSE TEST
(FDA 510(k) Clearance)

K993519 is an FDA 510(k) clearance for the RAPIDPOINT ACCENT, MODEL 2000, RAPIDPOINT COAG HEPARIN TITRATION TEST, RAPIDPOINT COAG PROTAMINE RESPONSE TEST, a Analyzer, Heparin, Automated (Class II — Special Controls, product code JOX), submitted by Cardiovascular Diagnostics, Inc. (Raleigh, US). The FDA issued a Cleared decision on January 14, 2000, 88 days after receiving the submission on October 18, 1999. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5680.