FDA Registration
Active
🇺🇸 United States
ACCU-CHEK Compact Plus, ACCU-CHEK Aviva Plus, ACCU-CHEK Nano
Reg #: 3001452053
·
FEI: 3001452053
·
Expires 2025
Products
3
Proprietary Names
1
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- SERVICE GRAPHICS, INC.
- Registration Number
- 3001452053
- FEI Number
- 3001452053
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 8350 ALLISON AVE.
- City
- INDIANAPOLIS
- State
- IN
- ZIP
- 46268
- Country
- US
Regulatory Submissions
- 510(k) Number
- K043474
Owner / Operator
- Firm Name
- SERVICE GRAPHICS, INC.
- Operator Number
- 9052909
- Address
- 8350 ALLISON AVE., --
- City
- Indianapolis
- State
- IN
- Postal Code
- 46268
- Country
- US
- Correspondent
- BILL - PRICE
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Glucose Dehydrogenase, Glucose | LFR | Class 2 | Clinical Chemistry | No | 2011-06-22 |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | Class 1 | Clinical Chemistry | No | 2011-06-22 |
| System, Test, Blood Glucose, Over The Counter | NBW | Class 2 | Clinical Chemistry | No | 2011-06-22 |
Proprietary Names
ACCU-CHEK Compact Plus, ACCU-CHEK Aviva Plus, ACCU-CHEK Nano
Establishment Types
Repack or Relabel Medical Device