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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 BK000043
Tradename HemoCue Low Hemoglobin Analyzing System
Device Name System, Hemoglobin, Automated
Original Applicant
HemoCue, Incorporated
9229 cranford drive
potomac,  MD  20854
Regulation Number864.5620
Classification Product Code
GKR  
Date Received11/13/2000
Decision Date 04/09/2001
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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