The following data is part of a premarket notification filed by Biotest Medical Corp. with the FDA for Easy Talk Blood Glucose Monitoring System Model: 6277.
| Device ID | K100560 |
| 510k Number | K100560 |
| Device Name: | EASY TALK BLOOD GLUCOSE MONITORING SYSTEM MODEL: 6277 |
| 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 | 2010-03-01 |
| Decision Date | 2010-05-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10850027494316 | K100560 | 000 |
| 10850027494309 | K100560 | 000 |
| 10850027494224 | K100560 | 000 |