# Di-Chem, Inc.

- Location (FDA's records): Champlin, MN
- FDA decisions: 6 (1982–2022): 6 510(k) clearances
- Product codes: KPO (5), LIF (1)
- Predicates its devices cite: 7 (0 its own); citations of its devices by later devices: 1 (0 its own)
- Recalls linked to its devices: 2 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Rockwell Medical: 1 (https://510kreport.com/company/rockwell-medical)
- Diasol, Inc.: 1 (https://510kreport.com/company/diasol)
- Advanced Renal Technologies, Inc.: 1 (https://510kreport.com/company/advanced-renal-technologies)
- C.G.H. Medical, Inc.: 1 (https://510kreport.com/company/cgh-medical)
- Gambro Renal Products: 1 (https://510kreport.com/company/gambro-renal-products)
- B. Braun Medizintechnologie GmbH: 1 (https://510kreport.com/company/b-braun-medizintechnologie)
- B. Braun Avitum AG: 1 (https://510kreport.com/company/b-braun-avitum)

## Firms that cite its devices most
- Dialysis Medical Solutions, LLC: 1 (https://510kreport.com/company/dialysis-medical-solutions)

## Its most-cited devices
- K012328: Hemo-Lyte Hemodialysis Grade Sodium Bicarbonate Powder (2002), cited by 1

## Recent decisions
- K202508: Hemo-Lyte C Cartridge (Aug 12, 2022)
- K171015: Citryte (Oct 13, 2017)
- K012328: Hemo-Lyte Hemodialysis Grade Sodium Bicarbonate Powder (Jan 18, 2002)
- K012547: Hemo-Lyte Hemodialysis Grade Sodium Bicarbonate Solution (Jan 18, 2002)
- K905217: Formasure Test Reagent (Apr 9, 1991)
- K823103: Dialysate Additives-Powder/Liquid (Nov 17, 1982)

Source page: https://510kreport.com/company/di-chem