The following data is part of a premarket notification filed by Acon Laboratories, Inc. with the FDA for On Call Express Blood Glucose Monitoring System.
| Device ID | K132086 |
| 510k Number | K132086 |
| Device Name: | ON CALL EXPRESS 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 |
| Subsequent Product Code | CGA |
| Subsequent Product Code | JJX |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-07-05 |
| Decision Date | 2013-12-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00370914006017 | K132086 | 000 |
| 20096295129155 | K132086 | 000 |
| 20096295129162 | K132086 | 000 |
| 20096295129247 | K132086 | 000 |
| 30096295129152 | K132086 | 000 |
| 50096295129163 | K132086 | 000 |
| 50096295129170 | K132086 | 000 |
| 30096295129183 | K132086 | 000 |
| 00096295129229 | K132086 | 000 |
| 00682607000081 | K132086 | 000 |
| 00682607000098 | K132086 | 000 |
| 00682607000074 | K132086 | 000 |
| 10682607557292 | K132086 | 000 |
| 10682607557322 | K132086 | 000 |
| 00692607000081 | K132086 | 000 |
| 20370914001009 | K132086 | 000 |
| 00370914003054 | K132086 | 000 |
| 20024291121842 | K132086 | 000 |