510(k) K073640 ยท LPS Urinary Homocystine (Nonquantitative) Test System
ARCHITECT HOMOCYSTEINE REAGENTS, CALIBRATORS AND CONTROLS
| Applicant | Axis-Shield Diagnostics, Ltd., Dundee, GB |
| Decision | Substantially Equivalent, Apr 24, 2008 |
| Received | Dec 26, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K073640
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.