FDA Registration
Active
🇭🇺 Hungary
Blood Gas
Reg #: 3006198300
·
FEI: 3006198300
·
Expires 2025
Products
12
Proprietary Names
1
Establishment Types
1
Classifications
12
Registration Details
- Registration Name
- Diamond Diagnostics Inc.
- Registration Number
- 3006198300
- FEI Number
- 3006198300
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 6 Oradna Street
- City
- Budapest
- Country
- HU
Regulatory Submissions
- 510(k) Number
- K080370
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
US Agent
- Business Name
- DIAMOND DIAGNOSTICS INC.
- Contact Name
- Kathy Fisher
- Address
- 333 Fiske St
- City
- Holliston
- State
- MA
- ZIP
- 01746
- Country
- US
- [email protected]
- Phone
- 508 4290450 ext. 358
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Electrode, Ion Specific, Potassium | CEM | Class 2 | Clinical Chemistry | No | 2020-09-01 |
| Assay, Carboxyhemoglobin | GHS | Class 2 | Hematology | No | 2020-09-01 |
| Electrode, Ion Specific, Calcium | JFP | Class 2 | Clinical Chemistry | No | 2020-09-01 |
| Electrode, Ion Specific, Sodium | JGS | Class 2 | Clinical Chemistry | No | 2020-09-01 |
| System, Hemoglobin, Automated | GKR | Class 2 | Hematology | No | 2020-09-01 |
| Calibrator, Multi-Analyte Mixture | JIX | Class 2 | Clinical Chemistry | No | 2020-09-01 |
| Multi-Analyte Controls, All Kinds (Assayed) | JJY | Class 1 | Clinical Chemistry | No | 2020-09-01 |
| Device, Hematocrit Measuring | JPI | Class 2 | Hematology | No | 2020-09-01 |
| Glucose Oxidase, Glucose | CGA | Class 2 | Clinical Chemistry | No | 2020-09-01 |
| Oximeter To Measure Hemoglobin | GLY | Class 2 | Hematology | No | 2020-09-01 |
| Electrode, Ion-Specific, Chloride | CGZ | Class 2 | Clinical Chemistry | No | 2020-09-01 |
| Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph | CHL | Class 2 | Clinical Chemistry | No | 2020-09-01 |
Proprietary Names
Blood Gas
Establishment Types
Export Device to the United States But Perform No Other Operation on Device