510(k) K093459 ยท MST Antibodies, Gliadin
ELIA GLIADIN DP IGA IMMUNOASSAY AND ELIA GLIADIN DP IGG IMMUNOASSAY, MODELS 14-5538-01, 14-5539-01
| Applicant | Phadia US, Inc., Portage MI, US |
| Decision | Substantially Equivalent, Aug 13, 2010 |
| Received | Nov 6, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K093459
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 30, 2023 | Phadia US Inc EliA GliadinDP IgG Well in the Phadia 2500EE instrument (Material Number 12410002)
EliA GliadinDP IgG is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to gliadin i Open, Classified |
MST | None listed |
| Jun 30, 2023 | Phadia US Inc Phadia 2500EE instrument -Intended for the in vitro semi-quantitative measurement of IgG antibodies directed to gliadin in human serum or plasma (Li-heparin, EDTA) to aid in the diagnosis of celiac di Open, Classified |
MST | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.