The following data is part of a premarket notification filed by Apex Biotechnology Corp. with the FDA for Glucosure Blood Glucose Monitoring System.
| Device ID | K002621 |
| 510k Number | K002621 |
| Device Name: | GLUCOSURE BLOOD GLUCOSE MONITORING SYSTEM |
| Classification | Glucose Oxidase, Glucose |
| Applicant | APEX BIOTECHNOLOGY CORP. 3600 HOLLY LN. N. SUITE 90 Plymouth, MN 55447 |
| Contact | Steven Crees |
| Correspondent | Steven Crees APEX BIOTECHNOLOGY CORP. 3600 HOLLY LN. N. SUITE 90 Plymouth, MN 55447 |
| Product Code | CGA |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-08-23 |
| Decision Date | 2001-01-22 |