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Alere Technologies AS
Alere Technologies AS
Medical device manufacturer in Oslo, NO.
3
510(k) clearances
0
PMA approvals
0
recalls
Device types
PDJ Hemoglobin A1c Test System
2
LCP Assay, Glycosylated Hemoglobin
1
510(k) clearances
510(k)
Device
Decision
K182988
Afinion HbA1c Dx on Afinion 2
PDJ · Special
11/29/2018
SE
K180296
Afinion HbA1c Dx
PDJ · Traditional
05/07/2018
SE
K151809
Alere Afinion HbA1c, Alere Afinion AS100 Analyzer
LCP · Special
09/25/2015
SE