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U.S. Department of Health and Human Services

510(k) Premarket Notification

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ProductCode: JJE Applicant: ROCHE DIAGNOSTIC SYSTEMS, INC. Decision Date To: 05/08/2024
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cobas core immunochemistry system ROCHE DIAGNOSTIC SYSTEMS, INC. K962231 08/30/1996
roche cobas integra analyzer, reagent cassettes ROCHE DIAGNOSTIC SYSTEMS, INC. K951595 09/08/1995
roche cobas mira plus ROCHE DIAGNOSTIC SYSTEMS, INC. K920402 04/29/1992
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