Identity
- Trade Name
- Accu-Chek Inform II Base Unit FDA UDI
- Generic Name
- Point-of-care blood glucose monitoring system FDA UDI
- Model / Reference
- 07828411001 FDA UDI
Identifiers
- Catalog Number
- 07828411001 FDA UDI
- Primary DI / UDI-DI
- 04015630943319 FDA UDI
- 510(k) Number
- K121679 FDA UDI
- FDA Product Code
- NBW FDA UDI
- GMDN Term
- Point-of-care blood glucose monitoring system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1345 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Point-of-care blood glucose monitoring system
Accu-Chek Inform II Base Unit by Roche Diagnostics Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Point-of-care blood glucose monitoring system.
- OptiScanner 5000 Glucose Monitoring System — OPTISCAN BIOMEDICAL CORPORATION · Class II
- OptiScanner 5000 Disposable Cartridge — OPTISCAN BIOMEDICAL CORPORATION · Class II
- Accutrend Plus Meter Kit — Roche Diagnostics Corp. · Class II
- Accu-Chek Inform II Base Unit — Roche Diagnostics Corp. · Class II
- Accutrend Plus Meter Kit — Roche Diagnostics Corp. · Class II
- Accu-Chek Inform II Instrument with RF card — Roche Diagnostics Corp. · Class II
Cleared under the same submission
K121679 also covers:
- Accu-Chek Inform II Base Unit — Roche Diagnostics Corp.
- Accu-Chek Inform II Base Unit Light — Roche Diagnostics Corp.
- Accu-Chek Inform II Base Unit Light — Roche Diagnostics Corp.
- Accu-Chek Inform II Base Unit Light — Roche Diagnostics Corp.
- Accu-Chek Inform II Base Unit Light — Roche Diagnostics Corp.
- Accu-Chek Inform II Instrument with RF card — Roche Diagnostics Corp.
- Accu-Chek Inform II Instrument with RF card — Roche Diagnostics Corp.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Roche Diagnostics Corp.
Sources (1)
- FDA UDI d46480e1-f7f1-4aff-9bfd-bcb7eb40049e 35 fields · synced Jun 8, 2026