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U.S. Department of Health and Human Services

510(k) Premarket Notification
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New Search Biologics Clearance Letters and 510(k) Summaries Back To Search Results
Device Classification Name instrumentation for clinical multiplex test systems
510(k) Number BK130051
Tradename BioArray Imaging System (AIS) 400C
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 Received09/19/2013
Decision Date 05/21/2014
Decision substantially equivalent (SE)
Classification Advisory Committee Clinical Chemistry
Review Advisory Committee Clinical Chemistry
Type 510(k) Abbreviated
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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