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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 BK120052
Tradename DiaSpect Control HBT (-L, -M. -H)
Device Name Control, hemoglobin
Original Applicant
Diaspect Medical GMBH
800 e. leigh street
suite 206-5
richmond,  VA  23219
Regulation Number864.8625
Classification Product Code
GGM  
Date Received09/24/2012
Decision Date 11/14/2012
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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