K111371 is an FDA 510(k) clearance for the ON CALL CHOSEN BLOOD GLUCOSE MONITORING SYSTEM. This device is classified as a Glucose Oxidase, Glucose (Class II - Special Controls, product code CGA).
Submitted by ACON Laboratories, Inc. (San Diego, US). The FDA issued a Cleared decision on October 6, 2011, 143 days after receiving the submission on May 16, 2011.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1345.
| 510(k) Number | K111371 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 16, 2011 |
| Decision Date | October 06, 2011 |
| Days to Decision | 143 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | CGA — Glucose Oxidase, Glucose |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1345 |