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U.S. Department of Health and Human Services

510(k) Premarket Notification
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1 to 10 of 10 Results
ProductCode: JIX Applicant: BECKMAN COULTER, INC Decision Date To: 11/27/2014
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beckman coulter immage immunochemistry system low concentration immunoglobulin, beckman coulter BECKMAN COULTER, INC K130122 01/07/2014
access total bhcg (5th is) BECKMAN COULTER, INC. K130020 10/01/2013
synchron multi calibrator BECKMAN COULTER, INC. K110251 05/25/2011
immage immunochemistry systems high sensitivity cardiac c-reactive protein (ccrp) reagent BECKMAN COULTER, INC. K071002 06/21/2007
synchron cx delta clinical systems, creatinine test systems BECKMAN COULTER, INC. K071280 06/01/2007
synchron lx20 clinical systems, creatinine test systems BECKMAN COULTER, INC. K071277 06/01/2007
modification to synchron systems enzyme validator set levels 1 and 2 BECKMAN COULTER, INC. K032287 08/18/2003
beckman coulter immage immunochemistry system low concentration immunoglobulin a (igalc) reagent, beckman coulter cerebr BECKMAN COULTER, INC. K993549 02/01/2000
beckman coulter immage immunochemistry system low concentration immunoglobulin m (igmlc) reagent, beckman coulter cereb BECKMAN COULTER, INC. K993547 02/01/2000
synchron systems enzyme validator set levels 1 and 2 BECKMAN COULTER, INC. K984014 12/23/1998
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