510(k) K120609 ยท LBS Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl
VITROS CHEMISTRY PRODUCTS DHDL SLIDES
| Applicant | Ortho-Clinical Diagnostics, Inc., Rochester NY, US |
| Decision | Substantially Equivalent, Sep 7, 2012 |
| Received | Feb 29, 2012 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K120609
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 15, 2013 | Ortho-Clinical Diagnostics VITROS Chemistry Products dHDL Slides packaged as 300 slides/pack catalog number 6801895
VITROS dHDL Slides quantitatively measure HDL cholesterol (HDLC) concentration in serum and plasma using VITROS Terminated |
LBS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.