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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 K100024
Device Name TECO DIAGNOSTICS UTI DETECTION STRIPS
Applicant
TECO DIAGNOSTICS
1268 NORTH LAKEVIEW AVE.
ANAHEIM,  CA  92807
Applicant Contact KC CHEN
Correspondent
TECO DIAGNOSTICS
1268 NORTH LAKEVIEW AVE.
ANAHEIM,  CA  92807
Correspondent Contact KC CHEN
Regulation Number862.1510
Classification Product Code
JMT  
Subsequent Product Code
LJX  
Date Received01/05/2010
Decision Date 02/17/2011
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
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