K111353 is an FDA 510(k) clearance for the ACCU-CHECK COMBO SYSTEM. This device is classified as a Pump, Infusion, Insulin (Class II - Special Controls, product code LZG).
Submitted by Roche Diagnostics (Indianapolis, US). The FDA issued a Cleared decision on July 17, 2012, 428 days after receiving the submission on May 16, 2011.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5725.
| 510(k) Number | K111353 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 16, 2011 |
| Decision Date | July 17, 2012 |
| Days to Decision | 428 days |
| Submission Type | Abbreviated |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | LZG — Pump, Infusion, Insulin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5725 |