The following data is part of a premarket notification filed by Teco Diagnostics with the FDA for Urs-ig (glucose Test).
Device ID | K020175 |
510k Number | K020175 |
Device Name: | URS-IG (GLUCOSE TEST) |
Classification | Method, Enzymatic, Glucose (urinary, Non-quantitative) |
Applicant | TECO DIAGNOSTICS 1268 . LAKEVIEW AVE. Anaheim, CA 92807 |
Contact | Olivia Chen |
Correspondent | Olivia Chen TECO DIAGNOSTICS 1268 . LAKEVIEW AVE. Anaheim, CA 92807 |
Product Code | JIL |
CFR Regulation Number | 862.1340 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-01-17 |
Decision Date | 2002-03-21 |