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FDA 510(k) Applications Submitted by AGGREDYNE, INC.
FDA 510(k) Number
Submission Date
Device Name
Applicant
K122162
07/20/2012
AGGREGUIDE
AGGREDYNE, INC.
K163274
11/21/2016
AggreGuide A-100 AA Assay, AggreGuide A-100 Instrument
Aggredyne, Inc.
K181777
07/03/2018
AggreGuide A-100 ADP
Aggredyne, Inc.
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