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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, Alt/Sgpt
510(k) Number K832791
Device Name SERAYZER ALT/SGPT 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 Number862.1030
Classification Product Code
CKC  
Date Received08/19/1983
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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