FDA Registration
Active
🇺🇸 United States
On Call Vivid Blood Glucose Monitoring System
Reg #: 2531491
·
FEI: 3003516723
·
Expires 2025
Products
3
Proprietary Names
1
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- ACON LABORATORIES, INC.
- Registration Number
- 2531491
- FEI Number
- 3003516723
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 9440 Carroll Park Drive
- City
- SAN DIEGO
- State
- CA
- ZIP
- 92121
- Country
- US
Regulatory Submissions
- 510(k) Number
- K112653
Owner / Operator
- Firm Name
- ACON Laboratories, Inc.
- Operator Number
- 9063887
- Address
- 5850 Oberlin Drive, #340
- City
- San Diego
- State
- CA
- Postal Code
- 92121
- Country
- US
- Correspondent
- Catherine Shi
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Glucose Oxidase, Glucose | CGA | Class 2 | Clinical Chemistry | No | 2012-05-17 |
| System, Test, Blood Glucose, Over The Counter | NBW | Class 2 | Clinical Chemistry | No | 2012-05-17 |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | Class 1 | Clinical Chemistry | No | 2012-05-17 |
Proprietary Names
On Call Vivid Blood Glucose Monitoring System
Establishment Types
Manufacture Medical Device