The following data is part of a premarket notification filed by Cardiovascular Diagnostics, Inc. with the FDA for Rapidpoint Accent, Model 2000, Rapidpoint Coag Heparin Titration Test, Rapidpoint Coag Protamine Response Test.
| Device ID | K993519 |
| 510k Number | K993519 |
| Device Name: | RAPIDPOINT ACCENT, MODEL 2000, RAPIDPOINT COAG HEPARIN TITRATION TEST, RAPIDPOINT COAG PROTAMINE RESPONSE TEST |
| Classification | Analyzer, Heparin, Automated |
| Applicant | CARDIOVASCULAR DIAGNOSTICS, INC. 5301 DEPARTURE DR. Raleigh, NC 27616 |
| Contact | Peter Scott |
| Correspondent | Peter Scott CARDIOVASCULAR DIAGNOSTICS, INC. 5301 DEPARTURE DR. Raleigh, NC 27616 |
| Product Code | JOX |
| CFR Regulation Number | 864.5680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-10-18 |
| Decision Date | 2000-01-14 |
| Summary: | summary |