510(k) K171655 ยท GKZ Counter, Differential Cell
cobas m 511 integrated hematology analyzer
| Applicant | Roche Diagnostics Hematology, Inc., Westborough MA, US |
| Decision | Substantially Equivalent, Mar 2, 2018 |
| Received | Jun 5, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K171655
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 7, 2018 | Roche Diagnostics Hematology cobas m 511 integrated hematology analyzer, Model Number 07261691190
Product Usage:
The cobas m 511 integrated hematology analyzer is a quantitative, automated analyzer with cell locating capability. Terminated |
JOY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.