The following data is part of a premarket notification filed by Cardiovascular Diagnostics, Inc. with the FDA for Prothrombin Time Test Card.
| Device ID | K954625 |
| 510k Number | K954625 |
| Device Name: | PROTHROMBIN TIME TEST CARD |
| Classification | Test, Time, Prothrombin |
| Applicant | CARDIOVASCULAR DIAGNOSTICS, INC. 5301 DEPARTURE DR. Raleigh, NC 27616 |
| Contact | Diane N Peper |
| Correspondent | Diane N Peper CARDIOVASCULAR DIAGNOSTICS, INC. 5301 DEPARTURE DR. Raleigh, NC 27616 |
| Product Code | GJS |
| CFR Regulation Number | 864.7750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-09-27 |
| Decision Date | 1996-03-11 |
| Summary: | summary |