510(k) K031270 ยท DHX System, Test, Carcinoembryonic Antigen
ACCESS CEA REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY SYSTEMS
| Applicant | Beckman Coulter, Inc., Chaska MN, US |
| Decision | Substantially Equivalent, May 6, 2003 |
| Received | Apr 21, 2003 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K031270
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 6, 2015 | Beckman Coulter Inc. Access CEA Assay, Part No. 33200. For the quantitative determination of Carcinoembryonic Antigen (CEA) levels in human serum. Terminated |
DHX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.