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U.S. Department of Health and Human Services

510(k) Premarket Notification
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11 to 17 of 17 Results
ProductCode: JIX Applicant: ROCHE DIAGNOSTICS Decision Date To: 02/24/2017
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modification to calibrator for automatic systems (cfas) ROCHE DIAGNOSTICS CORP. K033501 11/20/2003
roche diagnostics ck-mb ROCHE DIAGNOSTICS CORP. K003158 12/18/2000
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
elecsys anti-tpo calset Roche Diagnostics K103171 02/11/2011
precinorm proteins in urine/csf (puc) and precipath puc Roche Diagnostics K050026 01/31/2005
roche diagnostics calibrator for automated systems, roche diagnostics calibrator calibrator for automated system Roche Diagnostics K101456 09/08/2010
total protein urine/csf gen.3 Roche Diagnostics K071239 09/14/2007
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