510(k) K873049 ยท CDT Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides
TRIGLYCERIDES GPO WITHOUT FREE GLYCEROL
| Applicant | Boehringer Mannheim Corp., Indianapolis IN, US |
| Decision | Substantially Equivalent, Aug 28, 1987 |
| Received | Aug 4, 1987 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K873049
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 14, 2018 | Roche Diagnostics Corporation cobas c 111 with ISE analyzers analyzer used in the following assays:
a)Creatinine plus ver.2
Catalog Number: 05401470190;
b)Triglycerides
Catalog Number: 04657594190 - Product Usage: Tina-quant Ap Terminated |
JJE | None listed |
| Jun 27, 2015 | Roche Diagnostics Operations, Inc. Triglycerides/Glycerol Blanked.
In vitro test for the quantitative determination of triglycerides in human serum and plasma or Roche/Hitachi MODULAR systems, and cobas c systems. Terminated |
CDT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.