510(k) K963424 ยท CDT Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides
OLYMPUS LIPASE REAGENT
| Applicant | Olympus America, Inc., Melville NY, US |
| Decision | Substantially Equivalent, Jan 14, 1997 |
| Received | Aug 30, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K963424
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 28, 2015 | Beckman Coulter Inc. Beckman Coulter, Lipase Assay, Catalog No. OSR6X30 Terminated |
CDT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.