510(k) K042479 ยท LCD Enzyme Immunoassay, Gentamicin
VITROS CHEMISTRY PRODUCTS GENT, TOBRA & VANC REAGENTS; VITROS CHEMISTYR PRODUCTS CALIBRATOR KITS 11, 13 & 14; VITROS CHE
| Applicant | Ortho-Clinical Diagnostics, Inc., Rochester NY, US |
| Decision | Substantially Equivalent, Jan 6, 2005 |
| Received | Sep 13, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K042479
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 1, 2005 | Ortho-Clinical Diagnostics VITROS Chemistry GENT Reagent REF 680 1711, *** Responsible firm on label: Ortho-Clinical Diagnostics Inc., Rochester, NY 14626. Each box contains 6 packs. Each pack contains liquid reagent for 50 Terminated |
LCD | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.