510(k) K951538 ยท CEP Radioimmunoassay, Luteinizing Hormone
BESURE ONE-=STEP HOME OVULATION PREDICTOR KIT
| Applicant | Syntron Bioresearch, Inc., Carlsbad CA, US |
| Decision | Substantially Equivalent, Jul 11, 1995 |
| Received | Apr 3, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K951538
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.