The following data is part of a premarket notification filed by Biomerieux, Inc. with the FDA for Vidas Toxo Igg Ii (txg) Assay Model 30 210.
| Device ID | K993319 |
| 510k Number | K993319 |
| Device Name: | VIDAS TOXO IGG II (TXG) ASSAY MODEL 30 210 |
| Classification | Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii |
| Applicant | BIOMERIEUX, INC. 1022 HINGHAM ST. Rockland, MA 02370 |
| Contact | Anna Demarinis |
| Correspondent | Anna Demarinis BIOMERIEUX, INC. 1022 HINGHAM ST. Rockland, MA 02370 |
| Product Code | LGD |
| CFR Regulation Number | 866.3780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-10-04 |
| Decision Date | 2000-05-22 |
| Summary: | summary |