510(k) K972697 ยท DGC Ige, Antigen, Antiserum, Control
AIA-PACK IGE II ASSAY
| Applicant | Tosoh Medics, Inc., Foster City CA, US |
| Decision | Substantially Equivalent, Oct 3, 1997 |
| Received | Jul 18, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K972697
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 5, 2018 | Tosoh Bioscience Inc ST-AIA PACK IGE II; Part Number: 025295
Assay, Allergy Terminated |
DGC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.