510(k) K973310 ยท CEP Radioimmunoassay, Luteinizing Hormone
TBD* ONE-STEP OVULATION PREDICTOR TEST
| Applicant | Armkel, LLC, Cranbury NJ, US |
| Decision | Substantially Equivalent, Oct 27, 1997 |
| Received | Sep 3, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K973310
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.