The following data is part of a premarket notification filed by Cardiovascular Diagnostics, Inc. with the FDA for Tas Results Data Acquisition System (traqs).
| Device ID | K981206 |
| 510k Number | K981206 |
| Device Name: | TAS RESULTS DATA ACQUISITION SYSTEM (TRAQS) |
| Classification | Instrument, Coagulation, Automated |
| Applicant | CARDIOVASCULAR DIAGNOSTICS, INC. 5301 DEPARTURE DR. Raleigh, NC 27616 |
| Contact | Greg Godlevski |
| Correspondent | Greg Godlevski CARDIOVASCULAR DIAGNOSTICS, INC. 5301 DEPARTURE DR. Raleigh, NC 27616 |
| Product Code | GKP |
| CFR Regulation Number | 864.5400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-04-01 |
| Decision Date | 1998-05-26 |
| Summary: | summary |