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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 BK040063
Tradename R & D Plasma Hemoglobin Hematology Control
Device Name Control, hemoglobin
Original Applicant
R & D Systems, Inc
614 mckinley place n.e.
minneapolis,  MN  55413
Regulation Number864.8625
Classification Product Code
GGM  
Date Received07/29/2004
Decision Date 09/17/2004
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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