The following data is part of a premarket notification filed by Infopia Co., Ltd with the FDA for Lipidpro Lipid Profile And Glucose Measuring System, Lipidpro Professional Lipid Profile And Glucose Measuring System..
| Device ID | K130295 |
| 510k Number | K130295 |
| Device Name: | LIPIDPRO LIPID PROFILE AND GLUCOSE MEASURING SYSTEM, LIPIDPRO PROFESSIONAL LIPID PROFILE AND GLUCOSE MEASURING SYSTEM. |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | INFOPIA CO., LTD 2341 W CRESCENT AVE #3 Anaheim, CA 92801 |
| Contact | Priscilla Chung |
| Correspondent | Priscilla Chung INFOPIA CO., LTD 2341 W CRESCENT AVE #3 Anaheim, CA 92801 |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-02-06 |
| Decision Date | 2013-06-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00763924540105 | K130295 | 000 |
| 10763924532107 | K130295 | 000 |
| 08809115905406 | K130295 | 000 |
| 08809115905413 | K130295 | 000 |
| 08809115905444 | K130295 | 000 |
| 00695684773014 | K130295 | 000 |
| 00695684773106 | K130295 | 000 |
| 00695684773120 | K130295 | 000 |
| 00695684774103 | K130295 | 000 |
| 00695684774127 | K130295 | 000 |
| 00695684775124 | K130295 | 000 |
| 00695684775506 | K130295 | 000 |
| 10763924550507 | K130295 | 000 |
| 00850006113064 | K130295 | 000 |
| 00860394001225 | K130295 | 000 |
| 00860394001256 | K130295 | 000 |
| 08809115904119 | K130295 | 000 |