K080194 is an FDA 510(k) clearance for the VIDAS CEA (S) ASSAY. This device is classified as a System, Test, Carcinoembryonic Antigen (Class II - Special Controls, product code DHX).
Submitted by bioMerieux, Inc. (Hazelwood, US). The FDA issued a Cleared decision on October 9, 2008, 258 days after receiving the submission on January 25, 2008.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.6010.
| 510(k) Number | K080194 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 25, 2008 |
| Decision Date | October 09, 2008 |
| Days to Decision | 258 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
| Product Code | DHX — System, Test, Carcinoembryonic Antigen |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.6010 |