510(k) K042520 ยท KLS Enzyme Immunoassay, Theophylline
VITROS CHEMISTRY PRODUCTS CAFFN REAGENT KIT AND TDM PERFORMANCE VERIFIERS I, II AND III
| Applicant | Ortho-Clinical Diagnostics, Inc., Rochester NY, US |
| Decision | Substantially Equivalent, Nov 30, 2004 |
| Received | Sep 16, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K042520
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.