The following data is part of a premarket notification filed by Biomerieux Vitek, Inc. with the FDA for Vidas Cmv Igm Assay.
| Device ID | K933549 |
| 510k Number | K933549 |
| Device Name: | VIDAS CMV IGM ASSAY |
| Classification | Antibody Igm,if, Cytomegalovirus Virus |
| 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 | LKQ |
| CFR Regulation Number | 866.3175 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-07-22 |
| Decision Date | 1994-08-02 |