The following data is part of a premarket notification filed by Biokit Usa, Inc. with the FDA for Rheumagen Aso T-control.
| Device ID | K904311 |
| 510k Number | K904311 |
| Device Name: | RHEUMAGEN ASO T-CONTROL |
| Classification | Antistreptolysin - Titer/streptolysin O Reagent |
| Applicant | BIOKIT USA, INC. LLISSA D'AMUNT 08186 BARCELONA, SPAIN Barcelona, ES |
| Contact | Odriozola |
| Correspondent | Odriozola BIOKIT USA, INC. LLISSA D'AMUNT 08186 BARCELONA, SPAIN Barcelona, ES |
| Product Code | GTQ |
| CFR Regulation Number | 866.3720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-09-19 |
| Decision Date | 1991-01-25 |