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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name instrumentation for clinical multiplex test systems
510(k) Number BK150270
Tradename Array Imaging System AS 400D
Device Name Instrumentation for Clinical Multiplex Test Systems
Original Applicant
BioArray Solutions, Ltd.
35 technology drive
suite 100
warren,  NJ  07059
Regulation Number862.2570
Classification Product Code
NSU  
Date Received05/22/2015
Decision Date 06/15/2015
Decision substantially equivalent (SE)
Classification Advisory Committee Clinical Chemistry
Review Advisory Committee Clinical Chemistry
Type 510(k) Special
Total Product Life Cycle (TPLC) TPLC Device Report
Reviewed by Third Party No
Expedited Review No
Combination Product No
In Vitro Product Yes
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