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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Vanillin Pyruvate, Ast/Sgot
510(k) Number K832790
Device Name SERALYZER AST/SGOT REAGENT STRIPS
Applicant
Miles Laboratories, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Miles Laboratories, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number862.1100
Classification Product Code
CIF  
Date Received08/16/1983
Decision Date 10/14/1983
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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