510(k) K863345 ยท DBF Ferritin, Antigen, Antiserum, Control
TANDEM(R)-M FERRITIN IMMUNOENZYMETRIC ASSAY
| Applicant | Hybritech, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Oct 8, 1986 |
| Received | Aug 29, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K863345
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 5, 2018 | Tosoh Bioscience Inc ST-AIA PACK Fer; Part Number: 025253
Assay, Anemia Terminated |
DBF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.