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U.S. Department of Health and Human Services

510(k) Premarket Notification

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ProductCode: LBS Applicant: ROCHE DIAGNOSTICS CORP. Decision Date To: 02/08/2023
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cobas 8000 modular series analyzer ROCHE DIAGNOSTICS CORP. K100853 09/09/2010
hdl-cholesterol plus 2nd generation ROCHE DIAGNOSTICS CORP. K033610 12/05/2003
modification to:cobas integra hdl-cholesterol plus 2nd generation ROCHE DIAGNOSTICS CORP. K012286 08/08/2001
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