Submission Details
| 510(k) Number | K163406 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 05, 2016 |
| Decision Date | July 11, 2017 |
| Days to Decision | 218 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
Cleared
Traditional
Mission Cholesterol Monitoring System, Mission Cholesterol Pro Monitoring System
Jul 2017
Decision
218d
Days
Class 1
Risk
About This 510(k) Submission
K163406 is an FDA 510(k) clearance for the Mission Cholesterol Monitoring System, Mission Cholesterol Pro Monitoring System, 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 July 11, 2017, 218 days after receiving the submission on December 5, 2016. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1175.
Device Classification
| Product Code | CHH — Enzymatic Esterase--oxidase, Cholesterol |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 862.1175 |
Manufacturer
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