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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: 09/05/2015
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elecsys c-peptide calset ROCHE DIAGNOSTICS CORP. K033873 02/13/2004
modification to calibrator for automatic systems (cfas) ROCHE DIAGNOSTICS CORP. K033501 11/20/2003
ammonia/ethanol/co2 calibrator, control normal, control abnormal ROCHE DIAGNOSTICS CORP. K031880 07/16/2003
calibrator for automated systems ROCHE DIAGNOSTICS CORP. K011226 06/25/2001
roche diagnostics ck-mb ROCHE DIAGNOSTICS CORP. K003158 12/18/2000
elecsys cortisol calcheck ROCHE DIAGNOSTICS CORP. K000576 03/21/2000
calibrator for automated systems (c.f.a.s.) ROCHE DIAGNOSTICS CORP. K990460 03/22/1999
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