510(k) K012252 ยท CEP Radioimmunoassay, Luteinizing Hormone
QUIK-CHECK OVULATION PREDICTOR
| Applicant | ACON Laboratories, Inc., Beverly MA, US |
| Decision | Substantially Equivalent, Aug 24, 2001 |
| Received | Jul 18, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K012252
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.