K203597 is an FDA 510(k) clearance for the Cholesterol2. This device is classified as a Enzymatic Esterase--oxidase, Cholesterol (Class I - General Controls, product code CHH).
Submitted by Abbott Ireland Diagnostics Division (Longford, IE). The FDA issued a Cleared decision on June 30, 2022, 568 days after receiving the submission on December 9, 2020.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1175.
| 510(k) Number | K203597 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 09, 2020 |
| Decision Date | June 30, 2022 |
| Days to Decision | 568 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 |