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U.S. Department of Health and Human Services

510(k) Premarket Notification

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ProductCode: GTJ Applicant: BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYT Decision Date To: 12/01/2022
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directigen meningitis combo test BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC K952791 05/30/1996
directigen meningitis combo test kit BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC K915330 03/23/1992
directigen neissena menningitidis group b test BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC K844407 01/25/1985
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