DI-CHEM, INC.

FDA Device Registration & Listing · Champlin, MN, US · Registration 2183415

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
2183415
FEI Number
2183415
Entity Name
DI-CHEM, INC.
City/State/Country
Champlin, MN, US
Establishment Address
12297 ENSIGN AVE. NORTH, Champlin, MN 55316, US
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device
Owner / Operator
DI-CHEM, INC. (Owner Number: 2183415)
Owner / Operator Contact Address
12297 ENSIGN AVE. NORTH, --, Champlin, MN 55316, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K171015
PMA Number
N/A

All Registered Proprietary Names

HEMO-LYTE C Citryte

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder) Gastroenterology, Urology Class 2 876.5820 2008-01-09
KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder) Gastroenterology, Urology Class 2 876.5820 2022-12-12
KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder) Gastroenterology, Urology Class 2 876.5820 2018-02-15

Official Correspondent

KYLE BUCHHOLZ

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

DI-CHEM, INC.
View consolidated registration, premarket clearance, and recall records for this applicant.
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2183415. Last updated year: 2026. Please use registration number 2183415 when referencing this establishment in official correspondence.
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