510(k) K911839 ยท JLX Radioimmunoassay, 17-Hydroxyprogesterone
NEONATAL BLOOD SPOT TEST 17-HYDROXPROG RADIO KIT
| Applicant | Pantex, Div. Bio-Analysis, Inc., Santa Monica CA, US |
| Decision | Substantially Equivalent, Jun 18, 1991 |
| Received | Apr 25, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K911839
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.