The following data is part of a premarket notification filed by Biokit Usa, Inc. with the FDA for Rheumajet Crp.
| Device ID | K910686 |
| 510k Number | K910686 |
| Device Name: | RHEUMAJET CRP |
| Classification | System, Test, C-reactive Protein |
| 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 | DCN |
| CFR Regulation Number | 866.5270 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-02-19 |
| Decision Date | 1991-03-19 |