The following data is part of a premarket notification filed by Infopia Co., Ltd with the FDA for Gluneo Lite Glucose Monitoring System, Gluneo Lite Professional Blood Glucose Monitoring System.
| Device ID | K132966 |
| 510k Number | K132966 |
| Device Name: | GLUNEO LITE GLUCOSE MONITORING SYSTEM, GLUNEO LITE PROFESSIONAL BLOOD GLUCOSE MONITORING SYSTEM |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | INFOPIA CO., LTD 1515 E KATELLA AVE UNIT 2115 Anaheim, CA 92805 |
| Contact | Priscilla Chung |
| Correspondent | Priscilla Chung INFOPIA CO., LTD 1515 E KATELLA AVE UNIT 2115 Anaheim, CA 92805 |
| Product Code | NBW |
| Subsequent Product Code | JJX |
| Subsequent Product Code | LFR |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-09-20 |
| Decision Date | 2013-12-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00793150629787 | K132966 | 000 |
| 08809115905369 | K132966 | 000 |
| 08809115905697 | K132966 | 000 |
| 08809115905703 | K132966 | 000 |
| 08809115905710 | K132966 | 000 |
| 08809115905727 | K132966 | 000 |
| 00793150629794 | K132966 | 000 |
| 00850002937428 | K132966 | 000 |
| 00860396000608 | K132966 | 000 |
| 00860394001263 | K132966 | 000 |
| 00860313000919 | K132966 | 000 |
| 00860396000615 | K132966 | 000 |
| 00793150629763 | K132966 | 000 |
| 00793150629770 | K132966 | 000 |
| 00860313000933 | K132966 | 000 |