Roche

FDA Regulatory Profile

Roche appears in FDA public data with 0 recalls, 2 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent 510(k) clearance was granted on June 5, 2012.

Summary

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

Known Names

roche-molecular-systems, roche-pharma, roche-diagnostics-corporation, roche-diabetes-care, roche diagnostics corporation, f hoffmann la roche, genentech usa, roche-diagnostics, roche-diagnostics-operations, roche-products

Recent 510(k) Clearances

K-NumberDeviceDate
K113793HOMOCYSTEINE TESTJune 5, 2012
K102914TQ HBA1C GEN3January 20, 2011