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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 BK040012
Tradename R&D Donor Checker Hematology Control
Original Applicant
R & D Systems, Inc
614 mckinley place n.e.
minneapolis,  MN  55413 US
Current 510(k) Holder
No 510(k) holder with active listings
No 510(k) contact with active listings identified
Regulation Number864.8625
Classification Product Code
GGM  
Date Received02/03/2004
Decision Date 03/05/2004
Decision substantially equivalent (SE)
Classification Advisory Committee Hematology
Review Advisory Committee Hematology
Type 510(k) Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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