510(k) K041863 ยท DHR System, Test, Rheumatoid Factor
VITROS CHEMISTRY PRODUCTS RF REAGENT, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 16, VITROS CHEMISTRY PRODUCTS FS
| Applicant | Ortho-Clinical Diagnostics, Inc., Rochester NY, US |
| Decision | Substantially Equivalent, Sep 20, 2004 |
| Received | Jul 9, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K041863
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 11, 2012 | Ortho-Clinical Diagnostics VITROS Chemistry Products Calibrator Kit 16, REF 680 1700, 5x1 mL --- Ortho-Clinical Diagnostics, Rochester, NY USA -- Ortho-Clinical Diagnostics High Wycomber, UK. VITROS Chemistry Products Calibrat Terminated |
DHR | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.