The following data is part of a premarket notification filed by Acon Laboratories, Inc. with the FDA for Mission Lipid Panel Monitoring System.
| Device ID | K180504 |
| 510k Number | K180504 |
| Device Name: | Mission Lipid Panel Monitoring System |
| Classification | Enzymatic Esterase--oxidase, Cholesterol |
| Applicant | ACON Laboratories, Inc. 10125 Mesa Rim Road San Diego, CA 92121 |
| Contact | Qiyi Xie |
| Correspondent | Qiyi Xie ACON Laboratories, Inc. 10125 Mesa Rim Road San Diego, CA 92121 |
| Product Code | CHH |
| Subsequent Product Code | JGY |
| Subsequent Product Code | LBR |
| CFR Regulation Number | 862.1175 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-02-26 |
| Decision Date | 2018-03-28 |