K002621 is an FDA 510(k) clearance for the GLUCOSURE BLOOD GLUCOSE MONITORING SYSTEM. This device is classified as a Glucose Oxidase, Glucose (Class II - Special Controls, product code CGA).
Submitted by Apex BioTechnology Corp. (Plymouth, US). The FDA issued a Cleared decision on January 22, 2001, 152 days after receiving the submission on August 23, 2000.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1345.
| 510(k) Number | K002621 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 23, 2000 |
| Decision Date | January 22, 2001 |
| Days to Decision | 152 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Statement |
| Product Code | CGA — Glucose Oxidase, Glucose |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1345 |