510(k) K010244 ยท CEP Radioimmunoassay, Luteinizing Hormone
SURE CHECK OVULATION PREDICTOR
| Applicant | Chembio Diagnostic Systems, Inc., Beverly MA, US |
| Decision | Substantially Equivalent, May 2, 2001 |
| Received | Jan 25, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K010244
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.