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Axis-Shield Poc AS
Axis-Shield Poc AS
Medical device manufacturer in Oslo, NO.
4
510(k) clearances
0
PMA approvals
0
recalls
Device types
LCP Assay, Glycosylated Hemoglobin
2
JFY Enzymatic Method, Creatinine
1
CHH Enzymatic Esterase--Oxidase, Cholesterol
1
510(k) clearances
510(k)
Device
Decision
K132031
Afinion Lipid Panel and Afinion Lipid Panel Control
CHH · Traditional
03/21/2014
SE
K110056
Afinion Analyzer
LCP · Traditional
02/15/2011
SE
K072409
Afinion Acr and Acr Control
JFY · Traditional
02/12/2008
SE
K050574
Afinion Hbalc
LCP · Traditional
07/22/2005
SE