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U.S. Department of Health and Human Services

510(k) Premarket Notification
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1 to 6 of 6 Results
ProductCode: CIG Applicant: Roche Diagnostics Decision Date To: 06/01/2024
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cobas c bilirubin total gen.3 Roche Diagnostics K131544 07/17/2013
cobas integra bilirubin direct gen.2 Roche Diagnostics K123965 02/28/2013
cobas 8000 modular series analyzer ROCHE DIAGNOSTICS CORP. K100853 09/09/2010
cobas integra 400/800 bilirubin total Roche Diagnostics K081193 01/16/2009
cobas integra bilirubin special and roche/hitachi bilrubin total, models 20737496 322, 03261638 190, and 11822713 226 ROCHE DIAGNOSTICS CORP. K063543 12/22/2006
roche diagnostics, boehringer mannheim liquid total bilirubin reagent ROCHE DIAGNOSTICS/BOEHRINGER MANNHEIM GMBH K981632 06/15/1998
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