Medical Device Manufacturer · US , Mchenry , IL

Di-Chem, Inc. - FDA 510(k) Cleared Devices

6 submissions · 6 cleared · Since 1982

Recent clearances: Hemo-Lyte C Cartridge, Citryte, HEMO-LYTE HEMODIALYSIS GRADE SODIUM BICARBONATE POWDER

6

Total

6

Cleared

0

Denied

FDA 510(k) Regulatory Record - Di-Chem, Inc. Gastroenterology & Urology ✕

5 devices

1-5 of 5

Cleared Aug 12, 2022

Hemo-Lyte C Cartridge

Gastroenterology & Urology · 711d

Cleared Oct 13, 2017

Gastroenterology & Urology · 192d

Cleared Jan 18, 2002

HEMO-LYTE HEMODIALYSIS GRADE SODIUM BICARBONATE POWDER

Gastroenterology & Urology · 179d

Cleared Jan 18, 2002

HEMO-LYTE HEMODIALYSIS GRADE SODIUM BICARBONATE SOLUTION

Gastroenterology & Urology · 164d

Cleared Apr 09, 1991

FORMASURE TEST REAGENT

Gastroenterology & Urology · 140d