The following data is part of a premarket notification filed by Acon Laboratories, Inc. with the FDA for On Call Sure Blood Glucose Monitoring System, On Call Sure Sync Blood Glucose Monitoring System.
| Device ID | K181527 |
| 510k Number | K181527 |
| Device Name: | On Call Sure Blood Glucose Monitoring System, On Call Sure Sync Blood Glucose Monitoring System |
| Classification | System, Test, Blood Glucose, Over The Counter |
| 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 | NBW |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-06-11 |
| Decision Date | 2018-10-03 |
| Summary: | summary |