The following data is part of a premarket notification filed by Biotest Medical Corp. with the FDA for Supercheck Plus Blood Glucose Monitoring System, Super Check Plus Multi Blood Glucose Monitoring System.
| Device ID | K141351 |
| 510k Number | K141351 |
| Device Name: | SUPERCHECK PLUS BLOOD GLUCOSE MONITORING SYSTEM, SUPER CHECK PLUS 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 42760 |
| Contact | Yuhua Chen |
| Correspondent | Yuhua Chen Biotest Medical Corp. NO.3-2, CHIEN-KUO ROAD, TEPZ TANTZU Taichung, TW 42760 |
| 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 | 2014-05-22 |
| Decision Date | 2015-05-19 |
| Summary: | summary |