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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
Original Applicant
R & D Systems, Inc
614 mckinley place n.e.
minneapolis,  MN  55413 US
Current 510(k) Holder *
614 mckinley pl., n.e.
minneapolis,  MN  55413
Current 510(k) Contact * alicia m felthauser
Regulation Number864.8625
Classification Product Code
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
Reviewed by Third Party No
Expedited Review No
Combination Product No
* Based on currently available data in Establishment Registration and Device Listing