K210933 is an FDA 510(k) clearance for the YSI 2900C Biochemistry Analyzer. This device is classified as a Glucose Oxidase, Glucose (Class II - Special Controls, product code CGA).
Submitted by Ysi, Inc. (Yellow Springs, US). The FDA issued a Cleared decision on September 30, 2024, 1281 days after receiving the submission on March 29, 2021.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1345.
| 510(k) Number | K210933 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 29, 2021 |
| Decision Date | September 30, 2024 |
| Days to Decision | 1281 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 |