The following data is part of a premarket notification filed by Taidoc Technology Corporation with the FDA for Fora Poct S10/td-4258 Blood Glucose Monitoring System.
| Device ID | K092688 |
| 510k Number | K092688 |
| Device Name: | FORA POCT S10/TD-4258 BLOOD GLUCOSE MONITORING SYSTEM |
| Classification | Glucose Dehydrogenase, Glucose |
| Applicant | TaiDoc Technology Corporation 3F,5F, NO.127 WUGONG 2ND RD, WUGU TOWNSHIP Taipei County, TW 24888 |
| Contact | Teling Hsu |
| Correspondent | Teling Hsu TaiDoc Technology Corporation 3F,5F, NO.127 WUGONG 2ND RD, WUGU TOWNSHIP Taipei County, TW 24888 |
| Product Code | LFR |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-09-01 |
| Decision Date | 2011-07-06 |
| Summary: | summary |