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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Nadh Oxidation/Nad Reduction, Ast/Sgot
510(k) Number K981650
Device Name AST/SGOT LIQUID REAGENT - KINETIC METHOD
Applicant
Teco Diagnostics
4925 E. Hunter Ave.
Anaheim,  CA  92807
Applicant Contact RHODA FILIPINA
Correspondent
Teco Diagnostics
4925 E. Hunter Ave.
Anaheim,  CA  92807
Correspondent Contact RHODA FILIPINA
Regulation Number862.1100
Classification Product Code
CIT  
Date Received05/11/1998
Decision Date 06/29/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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