510(k) K112790 ยท LPS Urinary Homocystine (Nonquantitative) Test System
AXIS-SHIELD 3-REAGENT HOMOCYSTEINE ASSAY FOR SYNCHRON
| Applicant | Axis-Shield Diagnostics, Ltd., Dundee, Scotland, GB |
| Decision | Substantially Equivalent, May 7, 2012 |
| Received | Sep 26, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K112790
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.