Di-Chem, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
6
Inspections
4
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K202508Hemo-Lyte C CartridgeAugust 12, 2022
K171015CitryteOctober 13, 2017
K012328HEMO-LYTE HEMODIALYSIS GRADE SODIUM BICARBONATE POWDERJanuary 18, 2002
K012547HEMO-LYTE HEMODIALYSIS GRADE SODIUM BICARBONATE SOLUTIONJanuary 18, 2002
K905217FORMASURE TEST REAGENTApril 9, 1991
K823103DIALYSATE ADDITIVES-POWDER/LIQUIDNovember 17, 1982