The following data is part of a premarket notification filed by Biokit Usa, Inc. with the FDA for Rheumagen Rf T-control.
| Device ID | K904310 |
| 510k Number | K904310 |
| Device Name: | RHEUMAGEN RF T-CONTROL |
| Classification | System, Test, Rheumatoid Factor |
| Applicant | BIOKIT USA, INC. CAN MALE LLISSA D'AMUNT Barcelona, ES 08186 |
| Contact | Odriozola |
| Correspondent | Odriozola BIOKIT USA, INC. CAN MALE LLISSA D'AMUNT Barcelona, ES 08186 |
| Product Code | DHR |
| CFR Regulation Number | 866.5775 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-09-19 |
| Decision Date | 1991-05-31 |