HEMOCUE WBC SYSTEM— 510(k) K071652
Substantially EquivalentHemocue AB
FDA 510(k) clearance K071652 for HEMOCUE WBC SYSTEM, Substantially Equivalent on 2007-10-25. Applicant: Hemocue AB. Device class: 2.
Clearance details
- Applicant
- Hemocue AB
- Product code
- Code GKL
- Device class
- Class 2
- Regulation
- 21 CFR 864.5200
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Lake Forest, CA, US
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