FDA Registration
Active
🇺🇸 United States
Citrapure Acid Concentrate
Reg #: 1065847
·
FEI: 3003040753
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- ROCKWELL MEDICAL
- Registration Number
- 1065847
- FEI Number
- 3003040753
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 604 High Tech Ct
- City
- GREER
- State
- SC
- ZIP
- 29650
- Country
- US
Regulatory Submissions
- 510(k) Number
- K062399
Owner / Operator
- Firm Name
- Rockwell Medical
- Operator Number
- 9030991
- Address
- 30142 WIXOM RD., --
- City
- Wixom
- State
- MI
- Postal Code
- 48393
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Dialysate Concentrate For Hemodialysis (Liquid Or Powder) | KPO | Class 2 | Gastroenterology, Urology | No | 2010-10-06 |
Proprietary Names
Citrapure Acid Concentrate
Establishment Types
Manufacture Medical Device