The following data is part of a premarket notification filed by Cardiovascular Diagnostics, Inc. with the FDA for Tas A Ptt Test Controls.
| Device ID | K961189 |
| 510k Number | K961189 |
| Device Name: | TAS A PTT TEST CONTROLS |
| Classification | Plasma, Coagulation Control |
| 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 | GGN |
| CFR Regulation Number | 864.5425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-03-26 |
| Decision Date | 1996-06-05 |
| Summary: | summary |