The following data is part of a premarket notification filed by Taidoc Technology Corporation with the FDA for Bioland G-423 Glood Glucose Monitoring System.
| Device ID | K113077 |
| 510k Number | K113077 |
| Device Name: | BIOLAND G-423 GLOOD GLUCOSE MONITORING SYSTEM |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | TaiDoc Technology Corporation 3F, 5F, NO 127 WUGONG 2ND RD WUGU TOWNSHIP, WUGU DIST New Taipei City, TW 24888 |
| Contact | Linda Ko |
| Correspondent | Linda Ko TaiDoc Technology Corporation 3F, 5F, NO 127 WUGONG 2ND RD WUGU TOWNSHIP, WUGU DIST New Taipei City, TW 24888 |
| Product Code | NBW |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-10-17 |
| Decision Date | 2012-08-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00146191202776 | K113077 | 000 |