FDA Registration
Active
🇺🇸 United States
LeadCare Plus
Reg #: 1218996
·
FEI: 1218996
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- Magellan Diagnostics, Inc.
- Registration Number
- 1218996
- FEI Number
- 1218996
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 101 Billerica Ave Bldg 4
- City
- N Billerica
- State
- MA
- ZIP
- 01862
- Country
- US
Regulatory Submissions
- 510(k) Number
- K142705
Owner / Operator
- Firm Name
- MAGELLAN Diagnostics INC.
- Operator Number
- 1218996
- Address
- 101 Billerica Ave Bldg 4, --
- City
- N Billerica
- State
- MA
- Postal Code
- 01862
- Country
- US
- Correspondent
- Vernon C Brown
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Lead, Atomic Absorption | DOF | Class 2 | Clinical Toxicology | No | 2015-11-11 |
Proprietary Names
LeadCare Plus
Establishment Types
Manufacture Medical Device
Develop Specifications But Do Not Manufacture At This Facility