Medical Device Manufacturer · US , Seguin , TX

Fujirebio Diagnostics Texas, Inc. - FDA 510(k) Cleared Devices

2 submissions · 2 cleared · Since 2008

Recent clearances: AB-TROL AND PRIVATE LABEL GLUCOSE CONTROL SOLUTION, FDTX GLUCOSE CONTROL SOLUTION

View 2 510(k) Devices ↓

2

Total

2

Cleared

0

Denied

FDA 510(k) Regulatory Record - Fujirebio Diagnostics Texas, Inc. Chemistry ✕

2 devices

1-2 of 2

Cleared Aug 08, 2008

AB-TROL AND PRIVATE LABEL GLUCOSE CONTROL SOLUTION

Chemistry · 189d

Cleared Aug 08, 2008

FDTX GLUCOSE CONTROL SOLUTION

Chemistry · 36d