The following data is part of a premarket notification filed by Infopia Co., Ltd. with the FDA for Gdh Professional Blood Glucose Monitoring System And Gdh Professional Led Blood Glucose Monitoring System.
| Device ID | K150274 |
| 510k Number | K150274 |
| Device Name: | GDH Professional Blood Glucose Monitoring System And GDH Professional LED Blood Glucose Monitoring System |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | Infopia Co., Ltd. 132, Anyangcheondong-ro, Dongan-gu Anyang, KR 431-836 |
| Contact | Na Yun Kim |
| Correspondent | Priscilla Chung LK Consulting Group USA, Inc. 2651 E Chapman Ave Ste 110 Fullerton, CA 92833 |
| Product Code | NBW |
| Subsequent Product Code | JJX |
| Subsequent Product Code | LFR |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-02-04 |
| Decision Date | 2015-08-26 |
| Summary: | summary |