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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, hemoglobin, automated
510(k) Number BK060048
Tradename HemoCue Hb 301 System
Device Name System, Hemoglobin, Automated
Original Applicant
HemoCue AB
kuvettgatan 1
angelholm,  SE-262 71, 
Regulation Number864.5620
Classification Product Code
GKR  
Date Received08/09/2006
Decision Date 10/05/2006
Decision substantially equivalent (SE)
Classification Advisory Committee Hematology
Review Advisory Committee Hematology
Type 510(k) Traditional
Total Product Life Cycle (TPLC) TPLC Device Report
Reviewed by Third Party No
Expedited Review No
Combination Product No
In Vitro Product Yes
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