510(k) K970612 ยท DBF Ferritin, Antigen, Antiserum, Control
SEALITE SCIENCES, INC. AQUALITE FERRITIN ASSAY
| Applicant | Sealite Sciences, Inc., Norcross GA, US |
| Decision | Substantially Equivalent, Jun 24, 1997 |
| Received | Feb 18, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K970612
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.