K180504 is an FDA 510(k) clearance for the Mission Lipid Panel Monitoring System. This device is classified as a Enzymatic Esterase--oxidase, Cholesterol (Class I - General Controls, product code CHH).
Submitted by ACON Laboratories, Inc. (San Diego, US). The FDA issued a Cleared decision on March 28, 2018, 30 days after receiving the submission on February 26, 2018.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1175.
| 510(k) Number | K180504 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 26, 2018 |
| Decision Date | March 28, 2018 |
| Days to Decision | 30 days |
| Submission Type | Special |
| Review Panel | Chemistry (CH) |
| Summary | Statement |
| Product Code | CHH — Enzymatic Esterase--oxidase, Cholesterol |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1175 |