DFI Co., Ltd.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
4
Inspections
1
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K181024DUS 2GP Reagent Strips, DUS 5 Reagent Strips, DUS 10 Reagent StripsMay 23, 2018
K171521DUS R-50S (Urine Chemistry system)February 16, 2018
K102188CYBOW READER, MODELS 300 & 720August 9, 2011
K052525CYBOW 11 SERIES REAGENT STRIPS FOR URINALYSISMarch 29, 2006