The following data is part of a premarket notification filed by Infopia Co., Ltd with the FDA for Gluco Lab Auto Coding, Model Igm-0022.
| Device ID | K091157 |
| 510k Number | K091157 |
| Device Name: | GLUCO LAB AUTO CODING, MODEL IGM-0022 |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | INFOPIA CO., LTD 13340 E. FIRESTONE BLVD. SUITE J Santa Fe Springs, CA 90670 |
| Contact | Priscilla Chung |
| Correspondent | Priscilla Chung INFOPIA CO., LTD 13340 E. FIRESTONE BLVD. SUITE J Santa Fe Springs, CA 90670 |
| Product Code | NBW |
| Subsequent Product Code | CGA |
| Subsequent Product Code | JJX |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-04-21 |
| Decision Date | 2009-11-17 |
| Summary: | summary |