The following data is part of a premarket notification filed by Apex Biotechnology Corp. with the FDA for Multisure Gk Link Blood Glucose And Ketone Monitoring System.
| Device ID | K201880 |
| 510k Number | K201880 |
| Device Name: | MultiSure GK Link Blood Glucose And Ketone Monitoring System |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | Apex Biotechnology Corp. No. 7, Li-Hsin Road V, Hsinchu Science Park Hsinchu, TW 30078 |
| Contact | Lisu Liu |
| Correspondent | Lisa Liu Apex Biotechnology Corp. No. 7, Li-Hsin Road V, Hsinchu Science Park Hsinchu, TW 30078 |
| Product Code | NBW |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-07-07 |
| Decision Date | 2021-10-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850017460065 | K201880 | 000 |
| 00850017460034 | K201880 | 000 |
| 00850017460027 | K201880 | 000 |
| 00850017460287 | K201880 | 000 |
| 00850017460089 | K201880 | 000 |