510(k) K885198 ยท JLX Radioimmunoassay, 17-Hydroxyprogesterone
17-ALPHA-HYDROXYPROGESTERONE (17-OH-P) NEO. RIA
| Applicant | Icn Biomedicals, Inc., Carson CA, US |
| Decision | Substantially Equivalent, Feb 23, 1989 |
| Received | Dec 16, 1988 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K885198
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.