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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: 08/27/2016
 
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ammonia/ethanol/co2 calibrator, control normal, control abnormal ROCHE DIAGNOSTICS CORP. K031880 07/16/2003
c.f.a.s. proteins, c.f.a.s. pac, precicontrol clinchem multi 1 & 2, precinorm protein & precipath protein Roche Diagnostics K133330 11/26/2013
calibrator for automated systems ROCHE DIAGNOSTICS CORP. K011226 06/25/2001
calibrator for automated systems (c.f.a.s.) ROCHE DIAGNOSTICS CORP. K990460 03/22/1999
calibrator for automated systems (c.f.a.s.) proteins with model 11355279160 ROCHE DIAGNOSTICS CORP. K080607 05/12/2008
calibrator for automated systems (c.f.a.s.), model 10759350 360 ROCHE DIAGNOSTICS CORP. K062319 09/13/2006
calibrator for automated systems prealbumin-aslo-ceruloplasmin (c.f.a.s. pac) ROCHE DIAGNOSTICS CORP. K040245 03/24/2004
calibrator for automated systems proteins in urine/csf ROCHE DIAGNOSTICS CORP. K040264 04/02/2004
cobas lithium ROCHE DIAGNOSTICS CORP. K063684 03/21/2008
elecsys anti-tpo calset Roche Diagnostics K103171 02/11/2011
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