The following data is part of a premarket notification filed by Virion (u.s.), Inc. with the FDA for Toxoplasma Gondii.
| Device ID | K864981 |
| 510k Number | K864981 |
| Device Name: | TOXOPLASMA GONDII |
| Classification | Antigens, Cf, Toxoplasma Gondii |
| Applicant | VIRION (U.S.), INC. 4 UPPERFIELD RD. Morristown, NJ 07960 |
| Contact | Edwin H Lennette,md |
| Correspondent | Edwin H Lennette,md VIRION (U.S.), INC. 4 UPPERFIELD RD. Morristown, NJ 07960 |
| Product Code | GMN |
| CFR Regulation Number | 866.3780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-12-22 |
| Decision Date | 1987-10-30 |