FDA Registration
Active
🇺🇸 United States
Coag-Sense PT/INR Monitoring System Patient Self Testing (Self Care) (03P70-03)
Reg #: 3007507465
·
FEI: 3007507465
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- COAGUSENSE INC
- Registration Number
- 3007507465
- FEI Number
- 3007507465
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 48377 Fremont Blvd Ste 113
- City
- Fremont
- State
- CA
- ZIP
- 94538
- Country
- US
Regulatory Submissions
- 510(k) Number
- K212779
Owner / Operator
- Firm Name
- Coagusense Inc
- Operator Number
- 10029003
- Address
- 48377 Fremont Blvd., ste 113
- City
- Fremont
- State
- CA
- Postal Code
- 94538
- Country
- US
- Correspondent
- Innetta Walker
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Test, Time, Prothrombin | GJS | Class 2 | Hematology | No | 2022-12-01 |
Proprietary Names
Coag-Sense PT/INR Monitoring System Patient Self Testing (Self Care) (03P70-03)
Establishment Types
Manufacture Medical Device