The following data is part of a premarket notification filed by Apex Biotechnology Corp. with the FDA for Bgm014 Blood Glucose Monitoring System, Bgm014 Pro Blood Glucose Monitoring System.
| Device ID | K161299 |
| 510k Number | K161299 |
| Device Name: | BGM014 Blood Glucose Monitoring System, BGM014 Pro 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 |
| Subsequent Product Code | JJX |
| Subsequent Product Code | LFR |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-05-09 |
| Decision Date | 2016-12-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10193489012453 | K161299 | 000 |
| 20888277675688 | K161299 | 000 |
| 10888277675698 | K161299 | 000 |
| 00847713000794 | K161299 | 000 |
| 00847713000787 | K161299 | 000 |
| 00847713000817 | K161299 | 000 |
| 00847713000800 | K161299 | 000 |