Medical Device Manufacturer · US , Indianapolos , IN

Roche - FDA 510(k) Cleared Devices

2 submissions · 2 cleared · Since 2011
2
Total
2
Cleared
0
Denied

FDA 510(k) Regulatory Record - Roche Chemistry ✕

2 devices
1-2 of 2
Cleared Jun 05, 2012
HOMOCYSTEINE TEST
K113793 · LPS
Chemistry · 165d
Cleared Jan 20, 2011
TQ HBA1C GEN3
K102914 · LCP
Chemistry · 111d
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