K223179 is an FDA 510(k) clearance for the Cholestech LDX ™ System. This device is classified as a Glucose Oxidase, Glucose (Class II - Special Controls, product code CGA).
Submitted by Alere San Diego, Inc. (San Diego, US). The FDA issued a Cleared decision on September 20, 2023, 344 days after receiving the submission on October 11, 2022.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1345.
| 510(k) Number | K223179 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 11, 2022 |
| Decision Date | September 20, 2023 |
| Days to Decision | 344 days |
| Submission Type | Dual Track |
| 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 |