The following data is part of a premarket notification filed by Biotest Medical Corp. with the FDA for Solov2 Blood Glucose Monitoring System.
| Device ID | K093764 |
| 510k Number | K093764 |
| Device Name: | SOLOV2 BLOOD GLUCOSE MONITORING SYSTEM |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | Biotest Medical Corp. NO.3-2, CHIEN-KUO ROAD, TEPZ TANTZU Taichung, TW 427 |
| Contact | Maggie Chu |
| Correspondent | Maggie Chu Biotest Medical Corp. NO.3-2, CHIEN-KUO ROAD, TEPZ TANTZU Taichung, TW 427 |
| Product Code | NBW |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-12-07 |
| Decision Date | 2010-03-02 |
| Summary: | summary |