The following data is part of a premarket notification filed by Cardiovascular Diagnostics, Inc. with the FDA for Thrombolytic Assessment System Prothrombin Time Test Controls.
| Device ID | K961814 |
| 510k Number | K961814 |
| Device Name: | THROMBOLYTIC ASSESSMENT SYSTEM PROTHROMBIN TIME TEST CONTROLS |
| Classification | Plasma, Control, Normal |
| Applicant | CARDIOVASCULAR DIAGNOSTICS, INC. 5301 DEPARTURE DR. Raleigh, NC 27616 |
| Contact | James M Clinton |
| Correspondent | James M Clinton CARDIOVASCULAR DIAGNOSTICS, INC. 5301 DEPARTURE DR. Raleigh, NC 27616 |
| Product Code | GIZ |
| Subsequent Product Code | GGC |
| Subsequent Product Code | GGN |
| Subsequent Product Code | GJS |
| CFR Regulation Number | 864.5425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-05-10 |
| Decision Date | 1996-08-13 |