510(k) K010871 ยท CDT Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides
TGL FLEX REAGENT CARTRIDGE
| Applicant | Dade Behring, Inc., Newark DE, US |
| Decision | Substantially Equivalent, Jul 9, 2001 |
| Received | Mar 23, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K010871
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 17, 2016 | Siemens Healthcare Diagnostics, Inc. Dimension Assays: Triglycerides (TGL) Terminated |
CDT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.