510(k) K150819 ยท CDT Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides
Triglycerides
| Applicant | Randox Laboratories Limited, Crumlin, GB |
| Decision | Substantially Equivalent, Aug 6, 2015 |
| Received | Mar 27, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K150819
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.