FDA Registration
Active
🇺🇸 United States
Aperio GT 450 DX
Reg #: 3006791373
·
FEI: 3006791373
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Leica Biosystems Imaging, Inc.
- Registration Number
- 3006791373
- FEI Number
- 3006791373
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 1360 Park Center Drive
- City
- Vista
- State
- CA
- ZIP
- 92081
- Country
- US
Regulatory Submissions
- 510(k) Number
- K232202
Owner / Operator
- Firm Name
- Leica Biosystems, division of Leica Microsystems, Inc.
- Operator Number
- 10054155
- Address
- 21440 W. Lake Cook Road, Floor 5
- City
- Deer Park
- State
- IL
- Postal Code
- 60010
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Whole Slide Imaging System | PSY | Class 2 | Pathology | No | 2024-04-25 |
Proprietary Names
Aperio GT 450 DX
Establishment Types
Manufacture Medical Device