K142089 is an FDA 510(k) clearance for the ACCU-CHEK AVIVA EXPERT SYSTEM. This device is classified as a Glucose Dehydrogenase, Glucose (Class II - Special Controls, product code LFR).
Submitted by Roche Diagnostics Corporation (Indianapolis, US). The FDA issued a Cleared decision on December 17, 2014, 138 days after receiving the submission on August 1, 2014.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1345.
| 510(k) Number | K142089 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 01, 2014 |
| Decision Date | December 17, 2014 |
| Days to Decision | 138 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | LFR — Glucose Dehydrogenase, Glucose |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1345 |