FDA Registration
Active
🇺🇸 United States
SmartLyte
Reg #: 3003030793
·
FEI: 3003030793
·
Expires 2025
Products
5
Proprietary Names
1
Establishment Types
1
Classifications
5
Registration Details
- Registration Name
- DIAMOND DIAGNOSTICS Inc
- Registration Number
- 3003030793
- FEI Number
- 3003030793
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 333 Fiske St
- City
- Holliston
- State
- MA
- ZIP
- 01746
- Country
- US
Regulatory Submissions
- 510(k) Number
- K082462
Owner / Operator
- Firm Name
- Diamond Diagnostics Inc.
- Operator Number
- 10028706
- Address
- 333 Fiske St
- City
- Holliston
- State
- MA
- Postal Code
- 01746
- Country
- US
- Correspondent
- Kathy Fisher
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Electrode, Ion Specific, Potassium | CEM | Class 2 | Clinical Chemistry | No | 2009-02-26 |
| Electrode, Ion Specific, Sodium | JGS | Class 2 | Clinical Chemistry | No | 2009-02-26 |
| Flame Photometry, Lithium | JIH | Class 2 | Clinical Toxicology | No | 2009-02-26 |
| Electrode, Ion Specific, Calcium | JFP | Class 2 | Clinical Chemistry | No | 2009-02-26 |
| Electrode, Ion-Specific, Chloride | CGZ | Class 2 | Clinical Chemistry | No | 2009-02-26 |
Proprietary Names
SmartLyte
Establishment Types
Manufacture Medical Device