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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name system, automated platelet aggregation
510(k) Number K122162
Model A-100
Device Name AGGREGUIDE
Original Applicant
AGGREDYNE, INC.
11874 south evelyn circle
houston,  TX  77071
Original Contact j. harbey knauss
Regulation Number864.5700
Classification Product Code
JOZ  
Date Received07/20/2012
Decision Date 12/20/2013
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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