Roche Professional Diagnostics

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
2
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K143534Elecsys CA-125 II assayAugust 6, 2015
K100903ANTI-HAVOctober 5, 2010