510(k) K812029 ยท CDT Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides
KODAK EKTACHEM CLIN. CHEM. SLIDES (TRIG)
| Applicant | Eastman Kodak Company, Walker MI, US |
| Decision | Substantially Equivalent, Aug 3, 1981 |
| Received | Jul 20, 1981 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K812029
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 22, 2014 | Ortho-Clinical Diagnostics VITROS CHEMISTRY PRODUCTS TRIG Slides, REF 133 6544, IVD
For in vitro diagnostic use only. VITROS Chemistry Products TRIG Slides quantitatively measure triglyceride (TRIG) concentration in serum an Terminated |
CDT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.