The following data is part of a premarket notification filed by Cardiovascular Diagnostics, Inc. with the FDA for Tas Analyzer, Model 1009.
| Device ID | K990566 |
| 510k Number | K990566 |
| Device Name: | TAS ANALYZER, MODEL 1009 |
| Classification | System, Multipurpose For In Vitro Coagulation Studies |
| Applicant | CARDIOVASCULAR DIAGNOSTICS, INC. 5301 DEPARTURE DR. Raleigh, NC 27616 |
| Contact | Peter Scott |
| Correspondent | Peter Scott CARDIOVASCULAR DIAGNOSTICS, INC. 5301 DEPARTURE DR. Raleigh, NC 27616 |
| Product Code | JPA |
| CFR Regulation Number | 864.5425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-02-22 |
| Decision Date | 1999-05-14 |
| Summary: | summary |