DFI Co., Ltd. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
DFI Co., Ltd. - FDA 510(k) Cleared Devices
Recent clearances: DUS 2GP Reagent Strips, DUS 5 Reagent Strips, DUS 10 Reagent Strips, DUS R-50S (Urine Chemistry system)
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.
510(k) submissions have been managed by Onbix Corporation as regulatory consultant.
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