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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, Alt/Sgpt
510(k) Number K875079
Device Name MODIFIED SERALYZER ALT/SGPT REAG. STRIPS & MODULE
Applicant
Miles Laboratories, Inc.
1127 Myrtle St.
P.O. Box 40
Elkhart,  IN  46514
Applicant Contact JOHN H ENGELMANN
Correspondent
Miles Laboratories, Inc.
1127 Myrtle St.
P.O. Box 40
Elkhart,  IN  46514
Correspondent Contact JOHN H ENGELMANN
Regulation Number862.1030
Classification Product Code
CKA  
Date Received12/09/1987
Decision Date 04/05/1988
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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