510(k) K921661 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
BOEHRINGER MANNHEIM/ HITACHI 911 ANALYZER
| Applicant | Boehringer Mannheim Corp., Indianapolis IN, US |
| Decision | Substantially Equivalent, Jun 30, 1992 |
| Received | Apr 7, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K921661
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 27, 2015 | Roche Diagnostics Operations, Inc. Triglycerides GPO.
In vitro test for the quantitative determination of triglycerides in human serum and plasma on the COBAS Integra 800 and 400 plus systems, cobas c111, Roche/Hitachi MODULAR systems Terminated |
JJE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.