URITEK-720+ URINE ANALYZER

Automated Urinalysis System

TECO DIAGNOSTICS

The following data is part of a premarket notification filed by Teco Diagnostics with the FDA for Uritek-720+ Urine Analyzer.

Pre-market Notification Details

Device IDK051526
510k NumberK051526
Device Name:URITEK-720+ URINE ANALYZER
ClassificationAutomated Urinalysis System
Applicant TECO DIAGNOSTICS 1268 NORTH LAKEVIEW AVE. Anaheim,  CA  92807
ContactStephanie Low
CorrespondentStephanie Low
TECO DIAGNOSTICS 1268 NORTH LAKEVIEW AVE. Anaheim,  CA  92807
Product CodeKQO  
Subsequent Product CodeCDM
Subsequent Product CodeCEN
Subsequent Product CodeJIL
Subsequent Product CodeJIN
Subsequent Product CodeJIO
Subsequent Product CodeJIR
Subsequent Product CodeJJB
Subsequent Product CodeJMT
Subsequent Product CodeJRE
Subsequent Product CodeLJX
CFR Regulation Number862.2900 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-06-08
Decision Date2005-08-16

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10673486000498 K051526 000

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