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Axis-Shield , Ltd.

FDA Regulatory Profile

Summary

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

Recent 510(k) Clearances

K-NumberDeviceDate
K042411ABBOTT IMX SIROLIMUS MICROPARTICLE ENZYME IMMUNOASSAYApril 7, 2005
K001981DIASTAT ANTI-CARDIOLIPIN IGA, MODEL FCAR 500August 21, 2000
K001574DIASTAT ANTI-CARDIOLIPIN IGG/IGM, MODEL FCAR 600June 9, 2000