FDA Registration
Active
🇺🇸 United States
HEMO-LYTE C
Reg #: 2183415
·
FEI: 2183415
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- DI-CHEM, INC.
- Registration Number
- 2183415
- FEI Number
- 2183415
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 12297 ENSIGN AVE. NORTH
- City
- Champlin
- State
- MN
- ZIP
- 55316
- Country
- US
Regulatory Submissions
- 510(k) Number
- K202508
Owner / Operator
- Firm Name
- DI-CHEM, INC.
- Operator Number
- 2183415
- Address
- 12297 ENSIGN AVE. NORTH, --
- City
- Champlin
- State
- MN
- Postal Code
- 55316
- Country
- US
- Correspondent
- KYLE D BUCHHOLZ
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Dialysate Concentrate For Hemodialysis (Liquid Or Powder) | KPO | Class 2 | Gastroenterology, Urology | No | 2022-12-12 |
Proprietary Names
HEMO-LYTE C
Establishment Types
Manufacture Medical Device