510(k) K042476 ยท LEG Enzyme Immunoassay, Valproic Acid
VITROS CHEMISTRY PRODUCTS VALP REAGENT; VITRO CHEMISTRY PRODUCTS CALIBRATOR KIT 12; VITROS CHEMISTRY PRODUCTS TDM PERFOS
| Applicant | Ortho-Clinical Diagnostics, Inc., Rochester NY, US |
| Decision | Substantially Equivalent, Dec 1, 2004 |
| Received | Sep 13, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K042476
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 11, 2018 | Ortho-Clinical Diagnostics VITROS Chemistry Products VALP Reagent Pack. For in vitro diagnostic use only.
CATALOG #(s): 6801710
INTENDED USE: For in vitro diagnostic use only. VITROS Chemistry Products VALP Reagent is used Terminated |
LEG | None listed |
| Feb 8, 2012 | Ortho-Clinical Diagnostics VITROS Valproic Acid (VALP) Reagent, REF/Catalog No. 6801710 --- Ortho- Clinical Diagnostics Rochester, NY USA -- Ortho- Clinical Diagnostics High Wycombe, UK --- An in vitro diagnostic.
For in vit Terminated |
LEG | None listed |
| Jun 4, 2005 | Ortho-Clinical Diagnostics VITROS VALP Reagent , REF 680 1710. Each box contains 6 packs. Each pack contains liquid reagent for 50 tests. Responsible firm on the label: Ortho-Clinical Diagnostics, Inc., Rochester, N.Y. 146 Terminated |
LEG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.