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Aggredyne, Inc.

FDA Regulatory Profile

Summary

Total Recalls
1
510(k) Clearances
3
Inspections
3
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1639-2022Class IIAggreGuide A-100 InstrumentJuly 23, 2019

Recent 510(k) Clearances

K-NumberDeviceDate
K181777AggreGuide A-100 ADPMarch 29, 2019
K163274AggreGuide A-100 AA Assay, AggreGuide A-100 InstrumentApril 5, 2017
K122162AGGREGUIDEDecember 20, 2013