The following data is part of a premarket notification filed by Apex Biotechnology Corp. with the FDA for Gluco Track Blood Glucose Monitoring System.
| Device ID | K062799 |
| 510k Number | K062799 |
| Device Name: | GLUCO TRACK BLOOD GLUCOSE MONITORING SYSTEM |
| Classification | Glucose Oxidase, Glucose |
| Applicant | APEX BIOTECHNOLOGY CORP. 5182 WEST 76TH ST. Minneapolis, MN 55439 |
| Contact | Bruce A Macfarlane |
| Correspondent | Bruce A Macfarlane APEX BIOTECHNOLOGY CORP. 5182 WEST 76TH ST. Minneapolis, MN 55439 |
| Product Code | CGA |
| Subsequent Product Code | JJX |
| Subsequent Product Code | NBW |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-09-19 |
| Decision Date | 2007-02-06 |
| Summary: | summary |