The following data is part of a premarket notification filed by R2 Diagnostics, Inc. with the FDA for Lupotek Correctin Vl, Lupotek Detectin Vl, Plasmacon La.
| Device ID | K083878 |
| 510k Number | K083878 |
| Device Name: | LUPOTEK CORRECTIN VL, LUPOTEK DETECTIN VL, PLASMACON LA |
| Classification | Reagent, Russel Viper Venom |
| Applicant | R2 DIAGNOSTICS, INC. 1801 COMMERCE DR. South Bend, IN 46628 |
| Contact | Marc D Goldford |
| Correspondent | Marc D Goldford R2 DIAGNOSTICS, INC. 1801 COMMERCE DR. South Bend, IN 46628 |
| Product Code | GIR |
| CFR Regulation Number | 864.8950 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-12-29 |
| Decision Date | 2010-06-25 |
| Summary: | summary |