The following data is part of a premarket notification filed by Apex Biotechnology Corp. with the FDA for Meg-2 Blood Glucose Monitoring System, Meg-2 50's Test Strip, Meg-2 Control Solution.
| Device ID | K101204 |
| 510k Number | K101204 |
| Device Name: | MEG-2 BLOOD GLUCOSE MONITORING SYSTEM, MEG-2 50'S TEST STRIP, MEG-2 CONTROL SOLUTION |
| Classification | Glucose Oxidase, Glucose |
| Applicant | APEX BIOTECHNOLOGY CORP. NO. 7, LI-HSIN ROAD V, HSINCHU SCIENCE PARK Hsinchu, TW 30078 |
| Contact | Hsue-mei Lee |
| Correspondent | Hsue-mei Lee APEX BIOTECHNOLOGY CORP. NO. 7, LI-HSIN ROAD V, HSINCHU SCIENCE PARK Hsinchu, TW 30078 |
| 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 | 2010-04-30 |
| Decision Date | 2011-08-31 |
| Summary: | summary |