510(k) K974508 ยท CEP Radioimmunoassay, Luteinizing Hormone
DBEST ONE-STEP OVULATION TEST
| Applicant | Ameritek, Inc., Seattle WA, US |
| Decision | Substantially Equivalent, Feb 2, 1998 |
| Received | Dec 1, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K974508
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.