510(k) K970467 ยท CEP Radioimmunoassay, Luteinizing Hormone
EZ SURE ONE STEP OVULATION PREDICTOR HOME TEST KIT
| Applicant | Excel Scientific, Inc., Yorba Linda CA, US |
| Decision | Substantially Equivalent, Mar 18, 1997 |
| Received | Feb 7, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K970467
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.