The following data is part of a premarket notification filed by Acon Laboratories, Inc. with the FDA for Acon On Call Vivid Pal Blood Glucose Monitoring System.
| Device ID | K122110 |
| 510k Number | K122110 |
| Device Name: | ACON ON CALL VIVID PAL BLOOD GLUCOSE MONITORING SYSTEM |
| Classification | Glucose Oxidase, Glucose |
| 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 | CGA |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-07-17 |
| Decision Date | 2012-11-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00682607001057 | K122110 | 000 |