510(k) K991707 ยท DHX System, Test, Carcinoembryonic Antigen
MODIFICATION TO ACCESS CEA REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 33200, 33205, 33209, 33206
| Applicant | Beckman, Chaska MN, US |
| Decision | Substantially Equivalent, Jun 1, 1999 |
| Received | May 19, 1999 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K991707
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.