510(k) K970085 ยท CGJ Radioimmunoassay, Follicle-Stimulating Hormone
SEALITE SCIENCES AQUALITE FSH
| Applicant | Sealite Sciences, Inc., Norcross GA, US |
| Decision | Substantially Equivalent, Feb 14, 1997 |
| Received | Jan 10, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K970085
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.