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Alere Technologies AS

FDA Regulatory Profile

Alere Technologies AS appears in FDA public data with 0 recalls, 3 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent 510(k) clearance was granted on November 29, 2018.

Summary

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

Recent 510(k) Clearances

K-NumberDeviceDate
K182988Afinion HbA1c Dx on Afinion 2November 29, 2018
K180296Afinion HbA1c DxMay 7, 2018
K151809Alere Afinion HbA1c, Alere Afinion AS100 AnalyzerSeptember 25, 2015

FDA data resources