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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name control, hemoglobin
510(k) Number BK030067
Tradename HemoCue Donor Hb Checker Control
Device Name Control, hemoglobin
Original Applicant
HemoCue, Incorporated
9229 cranford drive
potomac,  MD  20854
Regulation Number864.8625
Classification Product Code
GGM  
Date Received10/27/2003
Decision Date 12/19/2003
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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