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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: 12/09/2016
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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 c-peptide calset ROCHE DIAGNOSTICS CORP. K033873 02/13/2004
elecsys cortisol calcheck ROCHE DIAGNOSTICS CORP. K000576 03/21/2000
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
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