The following data is part of a premarket notification filed by American Diagnostica, Inc. with the FDA for Dv Test And Dvv Confirm.
| Device ID | K940490 |
| 510k Number | K940490 |
| Device Name: | DV TEST AND DVV CONFIRM |
| Classification | Reagent, Russel Viper Venom |
| Applicant | AMERICAN DIAGNOSTICA, INC. 222 RAILROAD AVE. Greenwich, CT 06830 |
| Contact | C Lada Sochynsky |
| Correspondent | C Lada Sochynsky AMERICAN DIAGNOSTICA, INC. 222 RAILROAD AVE. Greenwich, CT 06830 |
| Product Code | GIR |
| CFR Regulation Number | 864.8950 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-02-03 |
| Decision Date | 1995-04-05 |