K981985 is an FDA 510(k) clearance for the ACCESS CEA REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL 33200, 33205, 33206 & 33209. This device is classified as a System, Test, Carcinoembryonic Antigen (Class II - Special Controls, product code DHX).
Submitted by Beckman Coulter, Inc. (Chaska, US). The FDA issued a Cleared decision on September 24, 1998, 111 days after receiving the submission on June 5, 1998.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.6010.
| 510(k) Number | K981985 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 05, 1998 |
| Decision Date | September 24, 1998 |
| Days to Decision | 111 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 |