K990774 is an FDA 510(k) clearance for the ABBOTT ARCHITECT CEA. This device is classified as a System, Test, Carcinoembryonic Antigen (Class II - Special Controls, product code DHX).
Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on May 11, 1999, 63 days after receiving the submission on March 9, 1999.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.6010.
| 510(k) Number | K990774 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 09, 1999 |
| Decision Date | May 11, 1999 |
| Days to Decision | 63 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 |