The following data is part of a premarket notification filed by Biomerieux, Inc. with the FDA for Vidas Cea (s) Assay.
| Device ID | K080194 |
| 510k Number | K080194 |
| Device Name: | VIDAS CEA (S) ASSAY |
| Classification | System, Test, Carcinoembryonic Antigen |
| Applicant | BIOMERIEUX, INC. 595 ANGLUM RD. Hazelwood, MO 63042 |
| Contact | Nikita S Mapp |
| Correspondent | Nikita S Mapp BIOMERIEUX, INC. 595 ANGLUM RD. Hazelwood, MO 63042 |
| Product Code | DHX |
| CFR Regulation Number | 866.6010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-01-25 |
| Decision Date | 2008-10-09 |
| Summary: | summary |