HemoCue Hb 301 System— 510(k) K201217
Substantially EquivalentHemocue AB
FDA 510(k) clearance K201217 for HemoCue Hb 301 System, Substantially Equivalent on 2020-08-04. Applicant: Hemocue AB.
Clearance details
- Applicant
- Hemocue AB
- Product code
- Code GKR
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Ängelholm, SE
Data sourced from openFDA. This site is unofficial and independent of the FDA.