FDA Registration
Active
🇺🇸 United States
Clinitek Analyzer
Reg #: 1036362
·
FEI: 1036362
·
Expires 2025
Products
12
Proprietary Names
1
Establishment Types
2
Classifications
12
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
- K063276
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 |
|---|---|---|---|---|---|
| Nitroprusside, Ketones (Urinary, Non-Quant.) | JIN | Class 1 | Clinical Chemistry | No | 2018-06-20 |
| Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.) | JJB | Class 1 | Clinical Chemistry | No | 2018-06-20 |
| Test, Urine Leukocyte | LJX | Class 1 | Hematology | No | 2018-06-20 |
| Enzymatic Method, Creatinine | JFY | Class 2 | Clinical Chemistry | No | 2018-06-20 |
| Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) | JMT | Class 1 | Clinical Chemistry | No | 2018-06-20 |
| Blood, Occult, Colorimetric, In Urine | JIO | Class 2 | Hematology | No | 2018-06-20 |
| Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.) | CDM | Class 1 | Clinical Chemistry | No | 2018-06-20 |
| Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) | JIR | Class 1 | Clinical Chemistry | No | 2018-06-20 |
| Automated Urinalysis System | KQO | Class 1 | Clinical Chemistry | No | 2018-06-20 |
| Dye-Indicator, Ph (Urinary, Non-Quantitative) | CEN | Class 1 | Clinical Chemistry | No | 2018-06-20 |
| Refractometer For Clinical Use | JRE | Class 1 | Clinical Chemistry | No | 2018-06-20 |
| Method, Enzymatic, Glucose (Urinary, Non-Quantitative) | JIL | Class 2 | Clinical Chemistry | No | 2018-06-20 |
Proprietary Names
Clinitek Analyzer
Establishment Types
Repack or Relabel Medical Device
Remanufacture Medical Device