K232404 is an FDA 510(k) clearance for the CHOLESTEROL. This device is classified as a Enzymatic Esterase--oxidase, Cholesterol (Class I - General Controls, product code CHH).
Submitted by Medicon Hellas S.A (Gerakas, GR). The FDA issued a Cleared decision on August 9, 2024, 365 days after receiving the submission on August 10, 2023.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1175.
| 510(k) Number | K232404 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 10, 2023 |
| Decision Date | August 09, 2024 |
| Days to Decision | 365 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | CHH - Enzymatic Esterase--oxidase, Cholesterol |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1175 |