The following data is part of a premarket notification filed by Taidoc Technology Corporation with the FDA for Td-4277 Blood Glucose Monitoring System, Model 4277.
| Device ID | K100322 |
| 510k Number | K100322 |
| Device Name: | TD-4277 BLOOD GLUCOSE MONITORING SYSTEM, MODEL 4277 |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | TaiDoc Technology Corporation 6F, NO. 127, WUGONG 2ND RD WUGU TOWNSHIP Taipei County, TW 248 |
| Contact | Debra Liang |
| Correspondent | Debra Liang TaiDoc Technology Corporation 6F, NO. 127, WUGONG 2ND RD WUGU TOWNSHIP Taipei County, TW 248 |
| Product Code | NBW |
| Subsequent Product Code | JJX |
| Subsequent Product Code | LFR |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-02-04 |
| Decision Date | 2010-06-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816042011986 | K100322 | 000 |
| 00816042011924 | K100322 | 000 |
| 00816042011221 | K100322 | 000 |