The following data is part of a premarket notification filed by Acon Laboratories Inc. with the FDA for Mission Cholesterol Monitoring System, Mission Cholesterol Pro Monitoring System.
| Device ID | K163406 |
| 510k Number | K163406 |
| Device Name: | Mission Cholesterol Monitoring System, Mission Cholesterol Pro 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-12-05 |
| Decision Date | 2017-07-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10682607690098 | K163406 | 000 |
| 10682607690081 | K163406 | 000 |
| 10682607690074 | K163406 | 000 |
| 00682607690060 | K163406 | 000 |
| 10682607690050 | K163406 | 000 |