510(k) K820263 ยท CHH Enzymatic Esterase--Oxidase, Cholesterol
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES
| Applicant | Eastman Kodak Company, Mchenry IL, US |
| Decision | Substantially Equivalent, Feb 18, 1982 |
| Received | Feb 2, 1982 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K820263
| 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.