510(k) K052819 ยท DEM Alpha-1-Antitrypsin, Antigen, Antiserum, Control
VITROS CHEMISTRY PRODUCTS AAT REAGENT, CALIBRATOR KIT 99 AND AAT PERFORMANCE VERIFIERS I, II AND III
| Applicant | Ortho-Clinical Diagnostics, Inc., Rochester NY, US |
| Decision | Substantially Equivalent, Dec 23, 2005 |
| Received | Oct 4, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K052819
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.