The following data is part of a premarket notification filed by Cardiovascular Diagnostics, Inc. with the FDA for Hmp Controls (tas) Rapidpoint.
| Device ID | K994159 |
| 510k Number | K994159 |
| Device Name: | HMP CONTROLS (TAS) RAPIDPOINT |
| Classification | Plasma, Coagulation Control |
| 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 | GGN |
| CFR Regulation Number | 864.5425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-12-09 |
| Decision Date | 2000-02-15 |
| Summary: | summary |