The following data is part of a premarket notification filed by Biokit Usa, Inc. with the FDA for Reumagen Asl.
| Device ID | K854991 |
| 510k Number | K854991 |
| Device Name: | REUMAGEN ASL |
| Classification | Antistreptolysin - Titer/streptolysin O Reagent |
| Applicant | BIOKIT USA, INC. CAN MALE LLISSA D'AMUNT Barcelona, ES 08186 |
| Contact | Angeles Rodriguez |
| Correspondent | Angeles Rodriguez BIOKIT USA, INC. CAN MALE LLISSA D'AMUNT Barcelona, ES 08186 |
| Product Code | GTQ |
| CFR Regulation Number | 866.3720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-12-12 |
| Decision Date | 1986-04-18 |