The following data is part of a premarket notification filed by Biotest Medical Corp. with the FDA for Smartest Glucowise Blood Glucose Monitoring System, And Smartest Glucoswise Multi Blood Glucose Monitoring System.
| Device ID | K122525 |
| 510k Number | K122525 |
| Device Name: | SMARTEST GLUCOWISE BLOOD GLUCOSE MONITORING SYSTEM, AND SMARTEST GLUCOSWISE MULTI 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 | Amanda Chiang |
| Correspondent | Amanda Chiang Biotest Medical Corp. NO.3-2, CHIEN-KUO ROAD, TEPZ TANTZU Taichung, TW 427 |
| Product Code | NBW |
| Subsequent Product Code | CGA |
| Subsequent Product Code | JJX |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-08-20 |
| Decision Date | 2013-05-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00852169003015 | K122525 | 000 |