DFI Co., Ltd. - FDA 510(k) Cleared Devices
4
Total
4
Cleared
0
Denied
DFI Co., Ltd. has 4 FDA 510(k) cleared medical devices. Based in Irvine, US.
Historical record: 4 cleared submissions from 2006 to 2018. Primary specialty: Chemistry.
Browse the FDA 510(k) cleared devices submitted by DFI Co., Ltd. Filter by specialty or product code using the sidebar.
FDA 510(k) Regulatory Record - DFI Co., Ltd.
4 devices
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