The following data is part of a premarket notification filed by Biomerieux Vitek, Inc. with the FDA for Vidas Toxoplasma Gondii Igm Asssay.
| Device ID | K923166 |
| 510k Number | K923166 |
| Device Name: | VIDAS TOXOPLASMA GONDII IGM ASSSAY |
| Classification | Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii |
| Applicant | BIOMERIEUX VITEK, INC. 1022 HINGHAM ST. Rockland, MA 02370 |
| Contact | Vicki Anastasi |
| Correspondent | Vicki Anastasi BIOMERIEUX VITEK, 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 | 1992-06-29 |
| Decision Date | 1993-02-25 |