HEMOCUE HB 301 ANALYZER, MODEL 121804 AND MICROCUVETTES, MODEL 111801— 510(k) K061047
Substantially EquivalentHemocue AB
FDA 510(k) clearance K061047 for HEMOCUE HB 301 ANALYZER, MODEL 121804 AND MICROCUVETTES, MODEL 111801, Substantially Equivalent on 2006-06-08. 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
- Lake Forest, CA, US
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