K000365 is an FDA 510(k) clearance for the ACCU-CHEK ADVANTAGE METER. This device is classified as a Glucose Oxidase, Glucose (Class II - Special Controls, product code CGA).
Submitted by Roche Diagnostics Corp. (Indianapolis, US). The FDA issued a Cleared decision on February 23, 2000, 19 days after receiving the submission on February 4, 2000.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1345.
| 510(k) Number | K000365 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 04, 2000 |
| Decision Date | February 23, 2000 |
| Days to Decision | 19 days |
| Submission Type | Special |
| 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 |