FDA Registration
Active
🇺🇸 United States
3 in 1 Troponin I/CK-MB/Myoglobin
Reg #: 2029372
·
FEI: 1000306617
·
Expires 2025
Products
3
Proprietary Names
1
Establishment Types
1
Classifications
3
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
- K050975
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 |
|---|---|---|---|---|---|
| Chromatographic Separation, Cpk Isoenzymes | JHT | Class 2 | Clinical Chemistry | No | 2017-12-17 |
| Immunoassay Method, Troponin Subunit | MMI | Class 2 | Clinical Chemistry | No | 2017-12-17 |
| Myoglobin, Antigen, Antiserum, Control | DDR | Class 2 | Immunology | No | 2017-12-17 |
Proprietary Names
3 in 1 Troponin I/CK-MB/Myoglobin
Establishment Types
Manufacture Medical Device