The following data is part of a premarket notification filed by Infopia Co., Ltd with the FDA for Lipidpro System.
| Device ID | K090405 |
| 510k Number | K090405 |
| Device Name: | LIPIDPRO SYSTEM |
| 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 Juhee Chung |
| Correspondent | Priscilla Juhee 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 | CHH |
| Subsequent Product Code | JGY |
| Subsequent Product Code | JJX |
| Subsequent Product Code | LBR |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-02-19 |
| Decision Date | 2009-12-01 |
| Summary: | summary |