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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name self-contained blood grouping
510(k) Number BK100008
Tradename ABORhCard
Device Name Self-contained Blood Grouping Device
Original Applicant
Micronics
8463 154th avenue ne
redmond,  WA  98052
Regulation Number864.9175
Classification Product Code
OQX  
Date Received02/18/2010
Decision Date 04/30/2010
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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