Roche Diagnostics Hematology

FDA Regulatory Profile

Summary

Total Recalls
1
510(k) Clearances
1
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2557-2018Class IIcobas m 511 integrated hematology analyzer, Model Number 07261691190 Product Usage: The cobas m May 7, 2018

Recent 510(k) Clearances

K-NumberDeviceDate
K171655cobas m 511 integrated hematology analyzerMarch 2, 2018