510(k) K974721 ยท CGI Radioimmunoassay, Estriol
UNCONJUGATED ESTRIOL ASSAY FOR THE BAYER IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM)
| Applicant | Bayer Corp., Tarrytown NY, US |
| Decision | Substantially Equivalent, Mar 3, 1998 |
| Received | Dec 18, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K974721
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.