FDA Registration
Active
🇺🇸 United States
Thermo Scientific Forma Controlled Rate Freezer (7459)
Reg #: 1523845
·
FEI: 1523845
·
Expires 2025
Products
1
Proprietary Names
6
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- THERMO FISHER SCIENTIFIC (ASHEVILLE) LLC
- Registration Number
- 1523845
- FEI Number
- 1523845
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 401 MILLCREEK RD.
- City
- MARIETTA
- State
- OH
- ZIP
- 45750
- Country
- US
Regulatory Submissions
- 510(k) Number
- K021042
Owner / Operator
- Firm Name
- THERMO FISHER SCIENTIFIC INC.
- Operator Number
- 2182773
- Address
- 168 Third Avenue, --
- City
- Waltham
- State
- MA
- Postal Code
- 02451
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Accessory, Assisted Reproduction | MQG | Class 2 | Obstetrics/Gynecology | No | 2008-01-16 |
Proprietary Names
Thermo Scientific Forma Controlled Rate Freezer (7459)
Thermo Scientific Forma Controlled Rate Freezer (7457)
Thermo Scientific Forma Controlled Rate Freezer (7476)
Thermo Scientific Forma Controlled Rate Freezer (7456)
Thermo Scientific Forma Controlled Rate Freezer (7458)
Thermo Scientific Forma Controlled Rate Freezer (7475)
Establishment Types
Manufacture Medical Device
Complaint File Establishment per 21 CFR 820.198