The following data is part of a premarket notification filed by Ok Biotech Co., Ltd. with the FDA for Supercheck Pro Blood Glucose Monitoring System.
| Device ID | K213061 |
| 510k Number | K213061 |
| Device Name: | SuperCheck Pro Blood Glucose Monitoring System |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | OK BioTech Co., Ltd. No. 91, Sec. 2, Gongdao 5th Rd. Hsinchu City, TW 30070 |
| Contact | Laurie Liu |
| Correspondent | Laurie Liu OK BioTech Co., Ltd. No. 91, Sec. 2, Gongdao 5th Rd. Hsinchu City, TW 30070 |
| Product Code | NBW |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-09-22 |
| Decision Date | 2022-10-07 |