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FDA 510(k), K181751, HemoCue Hb 801 System
FDA 510(k), K181751, HemoCue Hb 801 System
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510(K) Number: K181751
Device Name: HemoCue Hb 801 System
Manufacturer: HemoCue AB
Device Classification Name: system, hemoglobin, automated
Regulation Number: 864.5620
Classification Product Code: GKR
Date Received: 07/02/2018
Decision Date: 02/01/2019
Regulation Medical Specialty: Hematology
Device Name: HemoCue Hb 801 System
Manufacturer: HemoCue AB
Device Classification Name: system, hemoglobin, automated
Regulation Number: 864.5620
Classification Product Code: GKR
Date Received: 07/02/2018
Decision Date: 02/01/2019
Regulation Medical Specialty: Hematology
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- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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