The following data is part of a premarket notification filed by Osang Healthcare Co., Ltd. with the FDA for Finetest Lite Smart Blood Glucose Monitoring System.
| Device ID | K201396 |
| 510k Number | K201396 |
| Device Name: | Finetest Lite Smart Blood Glucose Monitoring System |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | OSANG Healthcare Co., Ltd. 132, Anyangcheondong-Ro, Dongan-Gu Anyang, KR 14040 |
| Contact | Ik-hyeon Kim |
| Correspondent | Priscilla Chung LK Consulting Group USA, Inc. 1150 Roosevelt STE 200 Irvine, CA 92620 |
| Product Code | NBW |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-05-28 |
| Decision Date | 2020-10-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| MHC18490112 | K201396 | 000 |
| MHC18490012 | K201396 | 000 |
| MHC19902833060 | K201396 | 000 |
| MHC19902830672 | K201396 | 000 |