The following data is part of a premarket notification filed by Acon Laboratories, Inc. with the FDA for On Call Vivid Blood Glucose Monitoring Systems.
| Device ID | K112653 |
| 510k Number | K112653 |
| Device Name: | ON CALL VIVID BLOOD GLUCOSE MONITORING SYSTEMS |
| Classification | Single (specified) Analyte Controls (assayed And Unassayed) |
| 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 | JJX |
| Subsequent Product Code | CGA |
| Subsequent Product Code | NBW |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-09-12 |
| Decision Date | 2012-04-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10682607556318 | K112653 | 000 |
| 20682607556223 | K112653 | 000 |
| 00682607000012 | K112653 | 000 |
| 00682607000036 | K112653 | 000 |
| 00682607000029 | K112653 | 000 |