The following data is part of a premarket notification filed by Apex Biotechnology Corp. with the FDA for Assure 4 Blood Glucose Monitoring System.
| Device ID | K070088 |
| 510k Number | K070088 |
| Device Name: | ASSURE 4 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 | Thomas Y.s. Shen |
| Correspondent | Thomas Y.s. Shen 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-01-09 |
| Decision Date | 2007-02-16 |
| Summary: | summary |