510(k) K012593 ยท LBR Ldl & Vldl Precipitation, Hdl
VITROS CHEMISTRY PRODUCTS MAGNETIC HDL-CHOLESTEROL REAGENT, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 2
| Applicant | Ortho-Clinical Diagnostics, Inc., Rochester NY, US |
| Decision | Substantially Equivalent, Aug 30, 2001 |
| Received | Aug 10, 2001 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K012593
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 15, 2013 | Ortho-Clinical Diagnostics VITROS Chemistry Products CHOL Slides packaged as 300 slides/pack catalog number 1669829
VITROS CHOL Slides quantitatively measure cholesterol (CHOL) concentration in serum and plasma using VITROS 25 Terminated |
CHH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.