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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name urease and glutamic dehydrogenase, urea nitrogen
510(k) Number K060120
Device Name TECO CX3 REAGENT SET FOR SYNCHRON CX SYSTEM
Applicant
TECO DIAGNOSTICS
1268 NORTH LAKEVIEW AVE.
ANAHEIM,  CA  92807
Applicant Contact JIAN VAECHES
Correspondent
TECO DIAGNOSTICS
1268 NORTH LAKEVIEW AVE.
ANAHEIM,  CA  92807
Correspondent Contact JIAN VAECHES
Regulation Number862.1770
Classification Product Code
CDQ  
Subsequent Product Codes
CGA   CGX   CIC  
Date Received01/17/2006
Decision Date 03/27/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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