510(k) K983113 ยท CEP Radioimmunoassay, Luteinizing Hormone
BESURE PLUS ONE-STEP HOME OVULATION PREDICTOR KIT
| Applicant | Syntron Bioresearch, Inc., Carlsbad CA, US |
| Decision | Substantially Equivalent, Nov 18, 1998 |
| Received | Sep 4, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K983113
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.