The following data is part of a premarket notification filed by Cardiovascular Diagnostic Services with the FDA for Tas Analyzer.
| Device ID | K933092 |
| 510k Number | K933092 |
| Device Name: | TAS ANALYZER |
| Classification | Instrument, Coagulation, Automated |
| Applicant | CARDIOVASCULAR DIAGNOSTIC SERVICES 2810 MERIDIAN PKWY. SUITE 106 Durham, NC 27713 |
| Contact | Sharon Dermott |
| Correspondent | Sharon Dermott CARDIOVASCULAR DIAGNOSTIC SERVICES 2810 MERIDIAN PKWY. SUITE 106 Durham, NC 27713 |
| Product Code | GKP |
| CFR Regulation Number | 864.5400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-06-24 |
| Decision Date | 1993-11-15 |