The following data is part of a premarket notification filed by Dade Intl., Inc. with the FDA for Dade Innovin.
| Device ID | K974343 |
| 510k Number | K974343 |
| Device Name: | DADE INNOVIN |
| Classification | Test, Time, Prothrombin |
| Applicant | DADE INTL., INC. 2173 NW 99TH AVE. Miami, FL 33172 |
| Contact | Radames Riesgo |
| Correspondent | Radames Riesgo DADE INTL., INC. 2173 NW 99TH AVE. Miami, FL 33172 |
| Product Code | GJS |
| CFR Regulation Number | 864.7750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-11-19 |
| Decision Date | 1998-07-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414023496 | K974343 | 000 |
| 00630414023489 | K974343 | 000 |
| 00630414023472 | K974343 | 000 |
| 00842768003806 | K974343 | 000 |
| 00842768003790 | K974343 | 000 |
| 00842768003783 | K974343 | 000 |
| 00842768019586 | K974343 | 000 |
| 00842768019609 | K974343 | 000 |
| 00842768019593 | K974343 | 000 |