ROCKWELL MEDICAL

FDA Device Registration & Listing · WIXOM, MI, US · Registration 1835498

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
1835498
FEI Number
3001236991
Entity Name
ROCKWELL MEDICAL
City/State/Country
WIXOM, MI, US
Establishment Address
30142 WIXOM RD., WIXOM, MI 48393, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device
Owner / Operator
Rockwell Medical (Owner Number: 9030991)
Owner / Operator Contact Address
30142 WIXOM RD., --, Wixom, MI 48393, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K062399
PMA Number
N/A

All Registered Proprietary Names

Dri-Sate Acid Concentrate Mixes Bicarbonate Solution Concentrates for Bicarbonate Dialysis Citrapure Acid Concentrate

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 2010-10-06
KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder) Gastroenterology, Urology Class 2 876.5820 2010-10-06
KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder) Gastroenterology, Urology Class 2 876.5820 2010-10-06

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Rockwell Medical
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
1954315 ROCKWELL MEDICAL WASHINGTON, IA, US
1652176 ROCKWELL MEDICAL GRAPEVINE, TX, US

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1835498. Last updated year: 2026. Please use registration number 1835498 when referencing this establishment in official correspondence.
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