The following data is part of a premarket notification filed by Biokit Usa, Inc. with the FDA for Biokit Rpr.
| Device ID | K910541 |
| 510k Number | K910541 |
| Device Name: | BIOKIT RPR |
| Classification | Antigens, Nontreponemal, All |
| Applicant | BIOKIT USA, INC. CAN MALE LLISSA D'AMUNT Barcelona, ES 08186 |
| Contact | Ignacio Odriozola |
| Correspondent | Ignacio Odriozola BIOKIT USA, INC. CAN MALE LLISSA D'AMUNT Barcelona, ES 08186 |
| Product Code | GMQ |
| CFR Regulation Number | 866.3820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-02-04 |
| Decision Date | 1991-10-18 |