FDA Registration
Active
🇺🇸 United States
ARC Specialty Products, Balchem Corporation
Reg #: 3003936696
·
FEI: 3003936696
·
Expires 2025
Products
1
Proprietary Names
0
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- ARC Specialty Products, Balchem Corporation
- Registration Number
- 3003936696
- FEI Number
- 3003936696
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 95 Balchem Lane
- City
- Green Pond
- State
- SC
- ZIP
- 29446
- Country
- US
Regulatory Submissions
- 510(k) Number
- K902036
Owner / Operator
- Firm Name
- ARC Specialty Products, Balchem Corporation
- Operator Number
- 10026195
- Address
- 90 Crystal Run Rd., Ste. 202, 90 Crystal Run Rd.
- City
- Middletown
- State
- NY
- Postal Code
- 10941
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Sterilizer, Ethylene-Oxide Gas | FLF | Class 2 | General Hospital | No | 2008-09-08 |
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)