FDA Registration
Active
🇺🇸 United States
Diatron Pictus 400
Reg #: 3008425728
·
FEI: 3008425728
·
Expires 2025
Products
5
Proprietary Names
2
Establishment Types
1
Classifications
5
Registration Details
- Registration Name
- DIATRON US INC
- Registration Number
- 3008425728
- FEI Number
- 3008425728
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 12601 NW 115th Avenue, Suite A 113
- City
- Medley
- State
- FL
- ZIP
- 33178
- Country
- US
Regulatory Submissions
- 510(k) Number
- K101741
Owner / Operator
- Firm Name
- Diatron U.S. Inc
- Operator Number
- 10037043
- Address
- 12601 NW 115th Avenue Suite A 113
- City
- Medley
- State
- FL
- Postal Code
- 33178
- Country
- US
- Correspondent
- Frank Matuszak
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Glucose Oxidase, Glucose | CGA | Class 2 | Clinical Chemistry | No | 2011-10-12 |
| Electrode, Ion Specific, Potassium | CEM | Class 2 | Clinical Chemistry | No | 2011-10-12 |
| Electrode, Ion-Specific, Chloride | CGZ | Class 2 | Clinical Chemistry | No | 2011-10-12 |
| Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | JJE | Class 1 | Clinical Chemistry | No | 2011-10-12 |
| Electrode, Ion Specific, Sodium | JGS | Class 2 | Clinical Chemistry | No | 2011-10-12 |
Proprietary Names
Diatron Pictus 400
Diatron Pictus 700
Establishment Types
Repack or Relabel Medical Device