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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 K885156
Device Name CLINISTAT SGOT (AST) REAGENT TEST
Applicant
Heraeus Kulzer, Inc.
Diagnostics Division
P.O. Box 70
Elkhart,  IN  46515
Applicant Contact ROSANNE M SAVOL
Correspondent
Heraeus Kulzer, Inc.
Diagnostics Division
P.O. Box 70
Elkhart,  IN  46515
Correspondent Contact ROSANNE M SAVOL
Regulation Number862.1100
Classification Product Code
CIT  
Date Received12/15/1988
Decision Date 02/02/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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