FDA Registration
Active
🇭🇺 Hungary
URINALYSIS
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
- K101852
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 |
|---|---|---|---|---|---|
| Automated Urinalysis System | KQO | Class 1 | Clinical Chemistry | No | 2021-07-19 |
| Nitroprusside, Ketones (Urinary, Non-Quant.) | JIN | Class 1 | Clinical Chemistry | No | 2021-07-19 |
| Blood, Occult, Colorimetric, In Urine | JIO | Class 2 | Hematology | No | 2021-07-19 |
| Test, Urine Leukocyte | LJX | Class 1 | Hematology | No | 2021-07-19 |
| Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) | JIR | Class 1 | Clinical Chemistry | No | 2021-07-19 |
| Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) | JMT | Class 1 | Clinical Chemistry | No | 2021-07-19 |
| Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.) | JJB | Class 1 | Clinical Chemistry | No | 2021-07-19 |
| Acid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric) | JMA | Class 1 | Clinical Chemistry | No | 2021-07-19 |
| Refractometer For Clinical Use | JRE | Class 1 | Clinical Chemistry | No | 2021-07-19 |
| Method, Enzymatic, Glucose (Urinary, Non-Quantitative) | JIL | Class 2 | Clinical Chemistry | No | 2021-07-19 |
| Dye-Indicator, Ph (Urinary, Non-Quantitative) | CEN | Class 1 | Clinical Chemistry | No | 2021-07-19 |
| Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.) | CDM | Class 1 | Clinical Chemistry | No | 2021-07-19 |
Proprietary Names
URINALYSIS
Establishment Types
Export Device to the United States But Perform No Other Operation on Device