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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
510(k) Number K073370
Device Name TC MATRIX CLINICAL CHEMISTRY ANALYZER
Applicant
Teco Diagnostics
1268 N Lakeview Ave.
Anaheim,  CA  92807
Applicant Contact JIM VAECHHES
Correspondent
Teco Diagnostics
1268 N Lakeview Ave.
Anaheim,  CA  92807
Correspondent Contact JIM VAECHHES
Regulation Number862.2160
Classification Product Code
JJE  
Subsequent Product Codes
CDQ   CGA   CIX   CKA   JIX  
Date Received11/30/2007
Decision Date 05/08/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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