510(k) K970483 ยท CEW Radioimmunoassay, Parathyroid Hormone
AQUALITE INTACT PTH
| Applicant | Sealite Sciences, Inc., Norcross GA, US |
| Decision | Substantially Equivalent, Apr 14, 1997 |
| Received | Feb 10, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K970483
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.