510(k) K981985 ยท DHX System, Test, Carcinoembryonic Antigen
ACCESS CEA REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL 33200, 33205, 33206 & 33209
| Applicant | Beckman Coulter, Inc., Chaska MN, US |
| Decision | Substantially Equivalent, Sep 24, 1998 |
| Received | Jun 5, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K981985
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 1, 2006 | Beckman Coulter Inc Access Immunoassay system CEA, in vitro diagnostic, Part No. 33200 Terminated |
DHX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.