Medical Device Manufacturer · US , Irvine , CA

DFI Co., Ltd. - FDA 510(k) Cleared Devices

4 submissions · 4 cleared · Since 2006

4

Total

4

Cleared

0

Denied

FDA 510(k) Regulatory Record - DFI Co., Ltd. Chemistry ✕

4 devices

1-4 of 4

Cleared May 23, 2018

DUS 2GP Reagent Strips, DUS 5 Reagent Strips, DUS 10 Reagent Strips

Chemistry · 35d

Cleared Feb 16, 2018

DUS R-50S (Urine Chemistry system)

Chemistry · 268d

Cleared Aug 09, 2011

CYBOW READER, MODELS 300 & 720

Chemistry · 371d

Cleared Mar 29, 2006

CYBOW 11 SERIES REAGENT STRIPS FOR URINALYSIS

Chemistry · 196d