cobas m 511 integrated hematology analyzer— 510(k) K171655
Substantially EquivalentRoche Diagnostics Hematology, Inc.
FDA 510(k) clearance K171655 for cobas m 511 integrated hematology analyzer, Substantially Equivalent on 2018-03-02. Applicant: Roche Diagnostics Hematology, Inc..
Clearance details
- Applicant
- Roche Diagnostics Hematology, Inc.
- Product code
- Code GKZ
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Westborough, MA, US
Adverse events under product code GKZ
product code GKZ- Malfunction
- 1,205
- Total
- 1,205
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.