The following data is part of a premarket notification filed by Roche Diagnostics with the FDA for Accu-chek Inform Ii Blood Glucose Monitoring System.
| Device ID | K121679 |
| 510k Number | K121679 |
| Device Name: | ACCU-CHEK INFORM II BLOOD GLUCOSE MONITORING SYSTEM |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | Roche Diagnostics 9115 Hague Road Indianapolis, IN 46250 |
| Contact | Mike Flis |
| Correspondent | Mike Flis Roche Diagnostics 9115 Hague Road Indianapolis, IN 46250 |
| Product Code | NBW |
| Subsequent Product Code | JJX |
| Subsequent Product Code | LFR |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-06-07 |
| Decision Date | 2012-10-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613336155332 | K121679 | 000 |
| 07613336155318 | K121679 | 000 |
| 07613336141953 | K121679 | 000 |
| 04015630945757 | K121679 | 000 |
| 04015630943319 | K121679 | 000 |
| 04015630942473 | K121679 | 000 |