The following data is part of a premarket notification filed by Cardiovascular Diagnostic Services with the FDA for Tas Ptone.
| Device ID | K955843 |
| 510k Number | K955843 |
| Device Name: | TAS PTONE |
| Classification | Test, Time, Prothrombin |
| Applicant | CARDIOVASCULAR DIAGNOSTIC SERVICES 5301 DEPARTURE DR. Raleigh, NC 27604 |
| Contact | Cynthia Pritchard, Ph.d. |
| Correspondent | Cynthia Pritchard, Ph.d. CARDIOVASCULAR DIAGNOSTIC SERVICES 5301 DEPARTURE DR. Raleigh, NC 27604 |
| Product Code | GJS |
| CFR Regulation Number | 864.7750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-12-26 |
| Decision Date | 1996-03-18 |
| Summary: | summary |