FDA Registration
Active
🇺🇸 United States
DCJLR-N - directCHECK ACT-LR-Normal
Reg #: 3002721930
·
FEI: 2250033
·
Expires 2025
Products
1
Proprietary Names
5
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Accriva Diagnostics, Inc.
- Registration Number
- 3002721930
- FEI Number
- 2250033
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 6260 Sequence Drive
- City
- San Diego
- State
- CA
- ZIP
- 92121
- Country
- US
Regulatory Submissions
- 510(k) Number
- K120977
Owner / Operator
- Firm Name
- Accriva Diagnostics, Inc.
- Operator Number
- 10048042
- Address
- 6260 Sequence Drive
- City
- San Diego
- State
- CA
- Postal Code
- 92121
- Country
- US
- Correspondent
- Paula Morgan
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Plasma, Coagulation Control | GGN | Class 2 | Hematology | No | 2014-12-16 |
Proprietary Names
DCJLR-N - directCHECK ACT-LR-Normal
DCJ-005 - Protective Sleeves
DCJACT-A - directCHECK ACT+-Abnormal
DCJACT-N - directCHECK ACT+-Normal
DCJLR-A - directCHECK ACT-LR-Abnormal
Establishment Types
Manufacture Medical Device