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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 (Sequential Multiple, Continuous Flow) Clinical Use
510(k) Number K943376
Device Name OPERA SYSTEM
Applicant
Miles, Inc.
511 Benedict Ave.
Tarrytown,  NY  10591 - 509
Applicant Contact GABRIEL J MURACA, JR.
Correspondent
Miles, Inc.
511 Benedict Ave.
Tarrytown,  NY  10591 - 509
Correspondent Contact GABRIEL J MURACA, JR.
Regulation Number862.2150
Classification Product Code
JJC  
Date Received07/13/1994
Decision Date 09/14/1994
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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