The following data is part of a premarket notification filed by Taidoc Technology Corporation with the FDA for Td-4239 Blood Glucose Monitoring System And Td-4239 Multi Blood Glucose Monitoring System.
| Device ID | K101635 |
| 510k Number | K101635 |
| Device Name: | TD-4239 BLOOD GLUCOSE MONITORING SYSTEM AND TD-4239 MULTI BLOOD GLUCOSE MONITORING SYSTEM |
| Classification | System, Test, Blood Glucose, Over The Counter |
| 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 | NBW |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-06-10 |
| Decision Date | 2011-08-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816042010859 | K101635 | 000 |
| 00816042010842 | K101635 | 000 |