FDA Registration
Active
🇺🇸 United States
MICHCLONE ASSOCIATES, INC.
Reg #: 1831312
·
FEI: 1831312
·
Expires 2026
Products
4
Proprietary Names
10
Establishment Types
2
Classifications
4
Registration Details
- Registration Name
- MICHCLONE ASSOCIATES, INC.
- Registration Number
- 1831312
- FEI Number
- 1831312
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 1713 Larchwood Dr, STE B
- City
- Troy
- State
- MI
- ZIP
- 48083
- Country
- US
Regulatory Submissions
- 510(k) Number
- K842955
Owner / Operator
- Firm Name
- MICHCLONE ASSOCIATES, INC.
- Operator Number
- 1831312
- Address
- 1713 Larchwood Dr, STE B
- City
- Troy
- State
- MI
- Postal Code
- 48083
- Country
- US
- Correspondent
- NICHOLAS E TOBEN, D.M.A.
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Test, Sickle Cell | GHM | Class 2 | Hematology | No | 2008-02-20 |
| Fixative, Metallic Containing | LDX | Class 1 | Pathology | No | 1992-11-22 |
| Solution, Isotonic | JCE | Class 1 | Pathology | No | 2017-12-21 |
| Fixative, Formalin-Containing | LDY | Class 1 | Pathology | No | 1992-11-22 |
Proprietary Names
Hemoglobin M
B-5 Fixative
Blood Bank Saline Solution
Neutral Buffered Formalin
Carson's Modified Millonigs Formalin
Bouin's Fixative
Alcoholic Formalin
Zinc Formalin
Buffered Zinc Formalin
Test, Sickle Cell
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device