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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 K980902
Device Name N-ASSAY L AST/GOT
Applicant
Crestat Diagnostics, Inc.
910 Industry Dr.
Seattle,  WA  98056
Applicant Contact COLIN GETTY
Correspondent
Crestat Diagnostics, Inc.
910 Industry Dr.
Seattle,  WA  98056
Correspondent Contact COLIN GETTY
Regulation Number862.1100
Classification Product Code
CIT  
Date Received03/10/1998
Decision Date 03/26/1998
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
Predetermined Change
Control Plan Authorized		 No
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