The following data is part of a premarket notification filed by Teco Diagnostics with the FDA for Uritek 151 Urine Analyzer, Model Tc-151.
Device ID | K042421 |
510k Number | K042421 |
Device Name: | URITEK 151 URINE ANALYZER, MODEL TC-151 |
Classification | Automated Urinalysis System |
Applicant | TECO DIAGNOSTICS 1268 NORTH LAKEVIEW AVE. Anaheim, CA 92807 |
Contact | Tong S Chiah |
Correspondent | Tong S Chiah TECO DIAGNOSTICS 1268 NORTH LAKEVIEW AVE. Anaheim, CA 92807 |
Product Code | KQO |
Subsequent Product Code | CDM |
Subsequent Product Code | CEN |
Subsequent Product Code | JIL |
Subsequent Product Code | JIN |
Subsequent Product Code | JIO |
Subsequent Product Code | JIR |
Subsequent Product Code | JJB |
Subsequent Product Code | JMT |
Subsequent Product Code | JRE |
Subsequent Product Code | LJX |
CFR Regulation Number | 862.2900 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2004-09-07 |
Decision Date | 2005-05-09 |