The following data is part of a premarket notification filed by Apex Biotechnology Corp. with the FDA for Bgm009 Blood Glucose Monitoring System.
| Device ID | K141036 |
| 510k Number | K141036 |
| Device Name: | BGM009 BLOOD GLUCOSE MONITORING SYSTEM |
| Classification | System, Test, Blood Glucose, Over The Counter |
| 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 | NBW |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-04-22 |
| Decision Date | 2015-05-01 |
| Summary: | summary |