The following data is part of a premarket notification filed by Apex Biotechnology Corp. with the FDA for Modification To Glucosure Bgm System, Model 221100.
| Device ID | K011233 |
| 510k Number | K011233 |
| Device Name: | MODIFICATION TO GLUCOSURE BGM SYSTEM, MODEL 221100 |
| 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 |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-04-23 |
| Decision Date | 2001-05-18 |