K160944 is an FDA 510(k) clearance for the ACCU-CHEK Guide Blood Glucose Monitoring System. This device is classified as a System, Test, Blood Glucose, Over The Counter (Class II - Special Controls, product code NBW).
Submitted by Roche Diabetes Care, Inc. (Indianapolis, US). The FDA issued a Cleared decision on August 31, 2016, 148 days after receiving the submission on April 5, 2016.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1345.
| 510(k) Number | K160944 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 05, 2016 |
| Decision Date | August 31, 2016 |
| Days to Decision | 148 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | NBW - System, Test, Blood Glucose, Over The Counter |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1345 |