510(k) K190490 ยท CHH Enzymatic Esterase--Oxidase, Cholesterol
VITROS XT Chemistry Products TRIG-CHOL Slides
| Applicant | Ortho-Clinical Diagnostics, Inc., Rochester NY, US |
| Decision | Substantially Equivalent, Mar 27, 2019 |
| Received | Feb 28, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K190490
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.