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U.S. Department of Health and Human Services

510(k) Premarket Notification
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ProductCode: JLW Applicant: ROCHE DIAGNOSTICS Decision Date To: 06/04/2023
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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
elecsys tsh Roche Diagnostics K190773 04/16/2019
elecsys tsh assay, cobas e 801 immunoassay analyzer ROCHE DIAGNOSTICS K162606 01/23/2017
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