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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 BK140112
Tradename BioPlex? 2200 System
Device Name Instrumentation for Clinical Multiplex Test Systems
Original Applicant
Bio-Rad Laboratories
6565 185th ave ne
clinical diagnostics group
redmond,  WA  98052 5039
Regulation Number862.2570
Classification Product Code
NSU  
Date Received03/31/2014
Decision Date 07/23/2015
Decision substantially equivalent (SE)
Classification Advisory Committee Clinical Chemistry
Review Advisory Committee Clinical Chemistry
Type 510(k) Traditional
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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