The following data is part of a premarket notification filed by Acon Laboratories with the FDA for On Call Pro Blood Glucose Monitoring System.
| Device ID | K161867 |
| 510k Number | K161867 |
| Device Name: | On Call Pro Blood Glucose Monitoring System |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | ACON LABORATORIES 10125 MESA RIM ROAD San Diego, CA 92121 |
| Contact | Qiyi Xie |
| Correspondent | Qiyi Xie ACON LABORATORIES 10125 MESA RIM ROAD San Diego, CA 92121 |
| Product Code | NBW |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-07-07 |
| Decision Date | 2016-08-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20682607558319 | K161867 | 000 |
| 10682607558213 | K161867 | 000 |
| 00682607000289 | K161867 | 000 |
| 00682607000296 | K161867 | 000 |