FDA Registration
Active
🇺🇸 United States
Urine Analyzer
Reg #: 2029372
·
FEI: 1000306617
·
Expires 2025
Products
11
Proprietary Names
1
Establishment Types
1
Classifications
11
Registration Details
- Registration Name
- Diagnostic Automation/ Cortez Diagnostics Inc,.
- Registration Number
- 2029372
- FEI Number
- 1000306617
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 21250 Califa St Suite 102 and 116
- City
- Woodland Hills
- State
- CA
- ZIP
- 91367
- Country
- US
Regulatory Submissions
- 510(k) Number
- K101673
Owner / Operator
- Firm Name
- Diagnostic Automation /Cortez Diagnostics Inc.
- Operator Number
- 9011974
- Address
- 21250 Califa St,, SUITE 102 and 116
- City
- Woodland Hills
- State
- CA
- Postal Code
- 91367
- Country
- US
- Correspondent
- PAUL - SHAW
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Dye-Indicator, Ph (Urinary, Non-Quantitative) | CEN | Class 1 | Clinical Chemistry | No | 2017-12-17 |
| Test, Urine Leukocyte | LJX | Class 1 | Hematology | No | 2017-12-17 |
| Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) | JMT | Class 1 | Clinical Chemistry | No | 2017-12-17 |
| Automated Urinalysis System | KQO | Class 1 | Clinical Chemistry | No | 2017-12-17 |
| Nitroprusside, Ketones (Urinary, Non-Quant.) | JIN | Class 1 | Clinical Chemistry | No | 2017-12-17 |
| Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.) | CDM | Class 1 | Clinical Chemistry | No | 2017-12-17 |
| Blood, Occult, Colorimetric, In Urine | JIO | Class 2 | Hematology | No | 2017-12-17 |
| Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.) | JJB | Class 1 | Clinical Chemistry | No | 2017-12-17 |
| Method, Enzymatic, Glucose (Urinary, Non-Quantitative) | JIL | Class 2 | Clinical Chemistry | No | 2017-12-17 |
| Refractometer For Clinical Use | JRE | Class 1 | Clinical Chemistry | No | 2017-12-17 |
| Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) | JIR | Class 1 | Clinical Chemistry | No | 2017-12-17 |
Proprietary Names
Urine Analyzer
Establishment Types
Manufacture Medical Device