510(k) K964925 ยท CEP Radioimmunoassay, Luteinizing Hormone
SEALITE SCIENCES, INC. AQUALITE LH
| Applicant | Sealite Sciences, Inc., Norcross GA, US |
| Decision | Substantially Equivalent, Jan 22, 1997 |
| Received | Dec 9, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K964925
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.