510(k) K912318 ยท CHP Radioimmunoassay, Estradiol
ESTRADIOL SEROZYME ENZYME IMMUNO (MAG SOLID-PHASE)
| Applicant | Serono-Baker Diagnostics, Inc., Allentown PA, US |
| Decision | Substantially Equivalent, Jul 25, 1991 |
| Received | May 24, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K912318
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.