K201880 is an FDA 510(k) clearance for the MultiSure GK Link Blood Glucose and Ketone Monitoring System. This device is classified as a System, Test, Blood Glucose, Over The Counter (Class II - Special Controls, product code NBW).
Submitted by Apex BioTechnology Corp. (Hsinchu, TW). The FDA issued a Cleared decision on October 15, 2021, 465 days after receiving the submission on July 7, 2020.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1345.
| 510(k) Number | K201880 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 07, 2020 |
| Decision Date | October 15, 2021 |
| Days to Decision | 465 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | NBW — System, Test, Blood Glucose, Over The Counter |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1345 |