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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Analyzer, Chemistry, Micro, For Clinical Use
510(k) Number K872120
Device Name SERALYZER III BLOOD CHEMISTRY ANALYZER
Applicant
Miles Laboratories, Inc.
1127 Myrtle St.
P.O. Box 40
Elkhart,  IN  46514
Applicant Contact H ENGELMANN
Correspondent
Miles Laboratories, Inc.
1127 Myrtle St.
P.O. Box 40
Elkhart,  IN  46514
Correspondent Contact H ENGELMANN
Regulation Number862.2170
Classification Product Code
JJF  
Date Received06/01/1987
Decision Date 10/28/1987
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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