510(k) K855164 ยท CDT Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides
ENZYNATIC TRIGLYCERIDES REAGENT SET
| Applicant | Sterling Diagnostics, Inc., Sterling Heights MI, US |
| Decision | Substantially Equivalent, Feb 19, 1986 |
| Received | Dec 26, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K855164
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.