The following data is part of a premarket notification filed by Acon Laboratories, Inc. with the FDA for On Call Chosen Blood Glucose Monitoring System.
| Device ID | K111371 |
| 510k Number | K111371 |
| Device Name: | ON CALL CHOSEN BLOOD GLUCOSE MONITORING SYSTEM |
| Classification | Glucose Oxidase, Glucose |
| Applicant | ACON LABORATORIES, INC. 10125 MESA RIM RD. San Diego, CA 92121 |
| Contact | Qiyi Xie |
| Correspondent | Qiyi Xie ACON LABORATORIES, INC. 10125 MESA RIM RD. San Diego, CA 92121 |
| Product Code | CGA |
| Subsequent Product Code | JJX |
| Subsequent Product Code | NBW |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-05-16 |
| Decision Date | 2011-10-06 |
| Summary: | summary |