The following data is part of a premarket notification filed by Taidoc Technology Corporation with the FDA for Advocate Redi-code Dash Blood Glucose Monitoring System Model Td-4276.
Device ID | K093940 |
510k Number | K093940 |
Device Name: | ADVOCATE REDI-CODE DASH BLOOD GLUCOSE MONITORING SYSTEM MODEL TD-4276 |
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 |
CFR Regulation Number | 862.1345 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2009-12-22 |
Decision Date | 2010-04-23 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00884389176750 | K093940 | 000 |
00884389176743 | K093940 | 000 |
00884389106313 | K093940 | 000 |