The following data is part of a premarket notification filed by Teco Diagnostics, Inc. with the FDA for Uritek Tc-201 Urine Chemistry Test System.
Device ID | K152835 |
510k Number | K152835 |
Device Name: | URITEK TC-201 URINE CHEMISTRY TEST SYSTEM |
Classification | Enzymatic Method, Creatinine |
Applicant | TECO DIAGNOSTICS, INC. 1268 N. LAKEVIEW AVE. Anaheim, CA 92807 |
Contact | Yunyuan Vivian Wang |
Correspondent | Yunyuan Vivian Wang TECO DIAGNOSTICS, INC. 1268 N. LAKEVIEW AVE. Anaheim, CA 92807 |
Product Code | JFY |
Subsequent Product Code | JIR |
Subsequent Product Code | KQO |
CFR Regulation Number | 862.1225 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-09-29 |
Decision Date | 2016-03-07 |
Summary: | summary |