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. Device class: 2.
Clearance details
- Applicant
- Hemocue AB
- Product code
- Code GKR
- Device class
- Class 2
- Regulation
- 21 CFR 864.5620
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Ängelholm, SE
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