510(k) K953581 ยท CEP Radioimmunoassay, Luteinizing Hormone
FIRST RESPONSE OVULATION PREDICTOR TEST
| Applicant | Armkel, LLC, Cranbury NJ, US |
| Decision | Substantially Equivalent, Oct 3, 1995 |
| Received | Aug 1, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K953581
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.