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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: HemoCue Hb 301 System
Classification Name: SYSTEM, HEMOGLOBIN, AUTOMATED
Product Code: GKR
Device Class: 2
Regulation Number: 864.5620
Medical Specialty: Hematology
Registered Establishment Name: HEMOCUE AB
Registered Establishment Number: 3003044483
Premarket Submission Number: K061047
Owner/Operator: HemoCue AB
Owner/Operator Number: 9099323
Establishment Operations: Manufacturer
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