The following data is part of a premarket notification filed by Cardiovascular Diagnostics, Inc. with the FDA for Tas Hmt Controls.
| Device ID | K960234 |
| 510k Number | K960234 |
| Device Name: | TAS HMT CONTROLS |
| Classification | Plasma, Coagulation Control |
| Applicant | CARDIOVASCULAR DIAGNOSTICS, INC. 5301 DEPARTURE DR. Raleigh, NC 27616 |
| Contact | Cynthia Pritchard |
| Correspondent | Cynthia Pritchard CARDIOVASCULAR DIAGNOSTICS, INC. 5301 DEPARTURE DR. Raleigh, NC 27616 |
| Product Code | GGN |
| Subsequent Product Code | GGC |
| Subsequent Product Code | GIZ |
| Subsequent Product Code | JJX |
| CFR Regulation Number | 864.5425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-01-17 |
| Decision Date | 1996-05-30 |
| Summary: | summary |