510(k) K063804 ยท CDT Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides
OLYMPUS TRIGLYCERIDE TEST SYSTEM
| Applicant | Olympus America, Inc., Irving TX, US |
| Decision | Substantially Equivalent, Mar 23, 2007 |
| Received | Dec 22, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K063804
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 13, 2016 | Beckman Coulter Inc. Triglyceride, Catalog No. OSR6x118
Product Usage:Triglyceride OSR6x118 is intended as an Enzymatic colour test for the quantitative determination of triglyceride in human serum and plasma on Beckman Terminated |
CDT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.