The following data is part of a premarket notification filed by Apex Biotechnology Corp. with the FDA for Autosure Voice Ii Blood Glucose Monitoring System, Autosure Voice Ii Pro Blood Glucose Monitoring System, Autosure Blood Glucose Test Strips, Autosure Pro Blood Glucose Test Strips.
| Device ID | K150396 |
| 510k Number | K150396 |
| Device Name: | Autosure Voice II Blood Glucose Monitoring System, Autosure Voice II Pro Blood Glucose Monitoring System, Autosure Blood Glucose Test Strips, Autosure Pro Blood Glucose Test Strips |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | APEX BIOTECHNOLOGY CORP. NO. 7 LI-HSIN ROAD V, HSINCHU SCIENCE PARK Hsinchu, CN 30078 |
| Contact | Hsue-mei Lee |
| Correspondent | Hsue-mei Lee APEX BIOTECHNOLOGY CORP. NO. 7 LI-HSIN ROAD V, HSINCHU SCIENCE PARK Hsinchu, CN 30078 |
| Product Code | NBW |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-02-18 |
| Decision Date | 2015-10-14 |
| Summary: | summary |