Clearance Summary
RAPIDPOINT ACCENT, MODEL 2000, RAPIDPOINT COAG HEPARIN TITRATION TEST, RAPIDPOINT COAG PROTAMINE RESPONSE TEST received FDA 510(k) clearance under submission number K993519, sponsored by Cardiovascular Diagnostics, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 2000-01-14.
- Submission: K993519
- Applicant / Sponsor: Cardiovascular Diagnostics, Inc.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.5680
- Decision date: 2000-01-14
Classification & Regulation
This clearance is catalogued under FDA product code JOX and 21 CFR 864.5680, within the Hematology review panel as a Class II device.