Data / Medical devices / United States / Di-Chem, Inc.
Di-Chem, Inc.: FDA-registered device maker in Champlin, MN, United States, 6 510(k) clearances
Di-Chem, Inc. is registered with the FDA (registration 2183415) in Champlin, MN, United States. It lists 1 device type. The FDA files 6 510(k) clearances under its listings, the newest dated August 12, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2183415
- Address
- 12297 Ensign Ave. North, Champlin, MN, United States, 55316
- Owner or operator
- DI-CHEM, INC. (2183415)
- Roles
- Contract manufacturer, Manufacturer, Specification developer
- First device listed
- January 9, 2008
- Registered through
- 2026
- Brand names listed
- Citryte, HEMO-LYTE C
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Dialysate Concentrate For Hemodialysis (Liquid Or Powder) | KPO | 2 | Contract manufacturer, Manufacturer, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 12, 2022 | K202508 | Hemo-Lyte C Cartridge | KPO | Substantially Equivalent | Di-Chem, Inc. | accessdata.fda.gov |
| October 13, 2017 | K171015 | Citryte | KPO | Substantially Equivalent | Di-Chem, Inc. | accessdata.fda.gov |
| January 18, 2002 | K012547 | HEMO-LYTE HEMODIALYSIS GRADE SODIUM BICARBONATE SOLUTION | KPO | Substantially Equivalent | Di-Chem, Inc. | accessdata.fda.gov |
| January 18, 2002 | K012328 | HEMO-LYTE HEMODIALYSIS GRADE SODIUM BICARBONATE POWDER | KPO | Substantially Equivalent | Di-Chem, Inc. | accessdata.fda.gov |
| July 27, 1990 | K901471 | GC-1000 THROUGH GC-3005 ACID CONCENTRATE | KPO | Substantially Equivalent | Granite Chemical Co., Inc. | accessdata.fda.gov |
| November 17, 1982 | K823103 | DIALYSATE ADDITIVES-POWDER/LIQUID | KPO | Substantially Equivalent | Di-Chem, Inc. | accessdata.fda.gov |
Compare with other makers
Updated August 12, 2022. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.