The following data is part of a premarket notification filed by Biokit Usa, Inc. with the FDA for Toxogen.
| Device ID | K913467 |
| 510k Number | K913467 |
| Device Name: | TOXOGEN |
| Classification | Direct Agglutination Test, Toxoplasma Gondii |
| 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 | LLA |
| CFR Regulation Number | 866.3780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-08-05 |
| Decision Date | 1993-01-11 |