Aggredyne, Inc.

FDA Regulatory Profile

Aggredyne, Inc. appears in FDA public data with 1 recall, 3 510(k) clearances, 3 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1639-2022, Class II) was initiated on July 23, 2019. Its most recent 510(k) clearance was granted on March 29, 2019.

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