510(k) K991386 ยท CEP Radioimmunoassay, Luteinizing Hormone
EARLY OVULATION PREDICTOR (STICK), ONE STEP OVULATION PREDICTOR (STICK), OVULATION PREDICTOR (STICK)
| Applicant | Selfcare, Inc., Waltham MA, US |
| Decision | Substantially Equivalent, May 25, 1999 |
| Received | Apr 21, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K991386
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.