The following data is part of a premarket notification filed by Dsrv, Inc. with the FDA for Reagent, Russel Viper Venom - La Confirm.
| Device ID | K132076 |
| 510k Number | K132076 |
| Device Name: | REAGENT, RUSSEL VIPER VENOM - LA CONFIRM |
| Classification | Reagent, Russel Viper Venom |
| Applicant | DSRV, INC. 780 PARK NORTH BLVD. SUITE 100 Clarkston, GA 30021 |
| Contact | Lawanda Washington |
| Correspondent | Lawanda Washington DSRV, INC. 780 PARK NORTH BLVD. SUITE 100 Clarkston, GA 30021 |
| Product Code | GIR |
| CFR Regulation Number | 864.8950 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-07-03 |
| Decision Date | 2014-01-10 |