K203549 is an FDA 510(k) clearance for the Nova Primary Glucose Analyzer System. This device is classified as a Glucose Oxidase, Glucose (Class II - Special Controls, product code CGA).
Submitted by Nova Biomedical Corporation (Waltham, US). The FDA issued a Cleared decision on October 18, 2022, 683 days after receiving the submission on December 4, 2020.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1345.
| 510(k) Number | K203549 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 04, 2020 |
| Decision Date | October 18, 2022 |
| Days to Decision | 683 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 |