FDA Registration
Active
🇺🇸 United States
CEM - ELECTRODE, ION SPECIFIC, POTASSIUM JGS - ELECTRODE, ION SPECIFIC, SODIUM JFP - ELECTRODE, ION SPECIFIC, CALCIUM
Reg #: 1181121
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FEI: 1181121
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Expires 2025
Products
5
Proprietary Names
1
Establishment Types
1
Classifications
5
Registration Details
- Registration Name
- Fisher Diagnostics
- Registration Number
- 1181121
- FEI Number
- 1181121
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 8365 VALLEY PIKE
- City
- MIDDLETOWN
- State
- VA
- ZIP
- 22645
- Country
- US
Regulatory Submissions
- 510(k) Number
- K972673
Owner / Operator
- Firm Name
- Thermo Fisher Scientific
- Operator Number
- 2517925
- Address
- 168 Third Avenue, --
- City
- Waltham
- State
- MA
- Postal Code
- 02451
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Electrode, Ion Specific, Calcium | JFP | Class 2 | Clinical Chemistry | No | 2017-11-10 |
| Electrode, Ion-Specific, Chloride | CGZ | Class 2 | Clinical Chemistry | No | 2017-11-10 |
| Electrode, Ion Specific, Potassium | CEM | Class 2 | Clinical Chemistry | No | 2017-11-10 |
| Electrode, Ion Specific, Sodium | JGS | Class 2 | Clinical Chemistry | No | 2017-11-10 |
| Flame Photometry, Lithium | JIH | Class 2 | Clinical Toxicology | No | 2017-11-10 |
Proprietary Names
CEM - ELECTRODE, ION SPECIFIC, POTASSIUM JGS - ELECTRODE, ION SPECIFIC, SODIUM JFP - ELECTRODE, ION SPECIFIC, CALCIUM
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)