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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)
510(k) Number K170118
Device Name Scanostics UTI Check Application Test System
Applicant
Teco Diagnostics
1268 N Lakeview Ave.
Anaheim,  CA  92807
Applicant Contact Ling Koh
Correspondent
Teco Diagnostics
1268 N Lakeview Ave.
Anaheim,  CA  92807
Correspondent Contact Ling Koh
Regulation Number862.1510
Classification Product Code
JMT  
Subsequent Product Codes
KQO   LJX  
Date Received01/13/2017
Decision Date 09/21/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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