The following data is part of a premarket notification filed by Taidoc Technology Corporation with the FDA for Foracare Gd20 Blood Glucose Monitoring System.
| Device ID | K124040 |
| 510k Number | K124040 |
| Device Name: | FORACARE GD20 BLOOD GLUCOSE MONITORING SYSTEM |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | TaiDoc Technology Corporation 6F NO.127, WUGONG 2ND RD., WUGU DISTRICT New Taipei City, TW 241 |
| Contact | Pinjung Chen |
| Correspondent | Pinjung Chen TaiDoc Technology Corporation 6F NO.127, WUGONG 2ND RD., WUGU DISTRICT New Taipei City, TW 241 |
| Product Code | NBW |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-12-28 |
| Decision Date | 2013-05-16 |
| Summary: | summary |