FDA Registration
Active
🇺🇸 United States
EON Analyzer
Reg #: 1036362
·
FEI: 1036362
·
Expires 2025
Products
11
Proprietary Names
1
Establishment Types
2
Classifications
11
Registration Details
- Registration Name
- SCIENTIFIC SUPPLIES & TECHNOLOGY, INC.
- Registration Number
- 1036362
- FEI Number
- 1036362
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 7245 N.W. 43RD ST.
- City
- Doral
- State
- FL
- ZIP
- 33166
- Country
- US
Regulatory Submissions
- 510(k) Number
- K100060
Owner / Operator
- Firm Name
- SST International Inc.
- Operator Number
- 1036362
- Address
- 7245 N.W. 43RD ST., --
- City
- Miami
- State
- FL
- Postal Code
- 33166
- Country
- US
- Correspondent
- PETER F LUE
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Electrode, Ion Specific, Potassium | CEM | Class 2 | Clinical Chemistry | No | 2018-06-20 |
| Calibrator, Secondary | JIT | Class 2 | Clinical Chemistry | No | 2018-06-20 |
| Calibrator, Multi-Analyte Mixture | JIX | Class 2 | Clinical Chemistry | No | 2018-06-20 |
| Electrode, Ion-Specific, Chloride | CGZ | Class 2 | Clinical Chemistry | No | 2018-06-20 |
| Enzymatic, Carbon-Dioxide | KHS | Class 2 | Clinical Chemistry | No | 2018-06-20 |
| Biuret (Colorimetric), Total Protein | CEK | Class 2 | Clinical Chemistry | No | 2018-06-20 |
| Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | JJE | Class 1 | Clinical Chemistry | No | 2018-06-20 |
| Bromcresol Green Dye-Binding, Albumin | CIX | Class 2 | Clinical Chemistry | No | 2018-06-20 |
| Electrode, Ion Specific, Sodium | JGS | Class 2 | Clinical Chemistry | No | 2018-06-20 |
| Catalytic Methods, Amylase | JFJ | Class 2 | Clinical Chemistry | No | 2018-06-20 |
| Acid, Uric, Uricase (Colorimetric) | KNK | Class 1 | Clinical Chemistry | No | 2018-06-20 |
Proprietary Names
EON Analyzer
Establishment Types
Repack or Relabel Medical Device
Remanufacture Medical Device