K200215 is an FDA 510(k) clearance for the ADVIA Centaur CEA Assay. This device is classified as a System, Test, Carcinoembryonic Antigen (Class II - Special Controls, product code DHX).
Submitted by Siemens Healthcare Disgnostics, Inc. (Tarrytown, US). The FDA issued a Cleared decision on April 13, 2020, 76 days after receiving the submission on January 28, 2020.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.6010.
| 510(k) Number | K200215 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 28, 2020 |
| Decision Date | April 13, 2020 |
| Days to Decision | 76 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 |