cobas u 701 microscopy analyzer— 510(k) K200811
Substantially EquivalentRoche Diagnostics
FDA 510(k) clearance K200811 for cobas u 701 microscopy analyzer, Substantially Equivalent on 2020-11-06. Applicant: Roche Diagnostics.
Clearance details
- Applicant
- Roche Diagnostics
- Product code
- Code LKM
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Indianapolis, IN, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.