510(k) K012795 ยท MST Antibodies, Gliadin
DIAMEDIX IS-ANTI-GLIADIN IGG TEST SYSTEM
| Applicant | Diamedix Corp., Miami FL, US |
| Decision | Substantially Equivalent, Sep 28, 2001 |
| Received | Aug 21, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K012795
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 16, 2008 | Diamedix Corporation Is-anti-Gliadin IgG Enzyme Immunoassay Test Kit packaged in cardboard boxes with individual components secured within a foam insert. Catalog Number # 720-800. - Laboratory In-Vitro Diagnostic Assay in Terminated |
MST | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.