The following data is part of a premarket notification filed by Apex Bio Technology Corp with the FDA for Meg-2b Blood Glucose Monitoring System, Meg-2b Pro Blood Glucose Monitoring System.
| Device ID | K143750 |
| 510k Number | K143750 |
| Device Name: | MEG-2B Blood Glucose Monitoring System, MEG-2B Pro Blood Glucose Monitoring System |
| Classification | Glucose Oxidase, Glucose |
| Applicant | APEX BIO TECHNOLOGY CORP NO. 7, LI-HSIN ROAD V HSINCHU SCIENCE PARK Hsinchu, TW 30078 |
| Contact | Hsue-mei Lee |
| Correspondent | Hsue-mei Lee APEX BIO TECHNOLOGY CORP NO. 7, LI-HSIN ROAD V HSINCHU SCIENCE PARK Hsinchu, TW 30078 |
| Product Code | CGA |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-12-31 |
| Decision Date | 2015-05-07 |
| Summary: | summary |