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U.S. Department of Health and Human Services

510(k) Premarket Notification

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1 to 8 of 8 Results
ProductCode: JJE Applicant: ROCHE DIAGNOSTICS Decision Date To: 12/08/2022
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cobas pure integrated solutions, glucose hk gen.3, ise indirect na for gen.2, online dat methadone ii, elecsys tsh Roche Diagnostics K220134 09/16/2022
glucose hk gen.3, ise indirect na for gen.2, elecsys tsh, cobas pro integrated solutions Roche Diagnostics K191899 08/16/2019
cobas hba1c test, cobas b 101 system Roche Diagnostics Operations K163633 07/28/2017
elecsys tsh assay, cobas e 801 immunoassay analyzer ROCHE DIAGNOSTICS K162606 01/23/2017
cobas c513 analyzer, cobas c13 tina-quant hba1cdx gen.3 assay Roche Diagnostics Operations (RDO) K160571 12/19/2016
cobas 8000 modular series analyzer ROCHE DIAGNOSTICS CORP. K100853 09/09/2010
cobas c 111 analyzer Roche Diagnostics K071211 07/30/2007
cobas 6000 series system Roche Diagnostics K060373 03/13/2006
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