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U.S. Department of Health and Human Services

510(k) Premarket Notification

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1 to 10 of 17 Results
ProductCode: JIX Applicant: ROCHE DIAGNOSTICS Decision Date To: 10/22/2014
 
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c.f.a.s. proteins, c.f.a.s. pac, precico roche diagnostics K133330 11/26/2013
elecsys anti-tpo calset roche diagnostics K103171 02/11/2011
roche diagnostics calibrator for automat roche diagnostics K101456 09/08/2010
calibrator for automated systems (c.f.a. roche diagnostics corp. K080607 05/12/2008
cobas lithium roche diagnostics corp. K063684 03/21/2008
total protein urine/csf gen.3 roche diagnostics K071239 09/14/2007
calibrator for automated systems (c.f.a. roche diagnostics corp. K062319 09/13/2006
precinorm proteins in urine/csf (puc) an roche diagnostics K050026 01/31/2005
calibrator for automated systems protein roche diagnostics corp. K040264 04/02/2004
calibrator for automated systems prealbu roche diagnostics corp. K040245 03/24/2004
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