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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, hemoglobin, automated
510(K) Number K121752
Device Name AVIE TOTAL HB TEST SYSTEM
Applicant
MEC DYNAMICS CORP
90 rose orchard way
san jose,  CA  95134
Contact emmanual mpock
Regulation Number864.5620
Classification Product Code
GKR  
Date Received06/15/2012
Decision Date 01/07/2013
Decision substantially equivalent - CLIA submission (CS)
Classification Advisory Committee Hematology
Review Advisory Committee Hematology
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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