The following data is part of a premarket notification filed by Taidoc Technology Corporation with the FDA for Td-4268 Blood Glucose Monitoring System Td-4268 Multi Blood Glucose Monitoring System.
Device ID | K120042 |
510k Number | K120042 |
Device Name: | TD-4268 BLOOD GLUCOSE MONITORING SYSTEM TD-4268 MULTI BLOOD GLUCOSE MONITORING SYSTEM |
Classification | Glucose Dehydrogenase, Glucose |
Applicant | TaiDoc Technology Corporation 3F,5F, No.127, Wugong 2nd Rd. Wugu District New Taipei City, TW 24888 |
Contact | Meiru Li |
Correspondent | Meiru Li TaiDoc Technology Corporation 3F,5F, No.127, Wugong 2nd Rd. Wugu District New Taipei City, TW 24888 |
Product Code | LFR |
CFR Regulation Number | 862.1345 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2012-01-05 |
Decision Date | 2012-05-22 |
Summary: | summary |