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U.S. Department of Health and Human Services

510(k) Premarket Notification
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51 to 60 of 500 Results *
Decision Date From: 8/1/2003 Decision Date To: 04/23/2024 In Vitro Products: Yes
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bayer special chemistry calibrators BAYER DIAGNOSTICS CORP. K033380 12/16/2003
bayer special chemistry controls BAYER DIAGNOSTICS CORP. K033379 12/19/2003
bayer specific protein reference serum BAYER HEALTHCARE, LLC K033791 02/13/2004
bd automated microbiology system tetracycline - gp 0.5-16 ug/ml-gram positive id/ast or ast only phoenix panels BECTON, DICKINSON & CO. K032131 08/18/2003
bd phoenix automated microbiology system cefotaxime 0.5-64 ug/ml BD DIAGNOSTIC SYSTEMS K032153 09/11/2003
bd phoenix automated microbiology system - aztreonam 0.5-64 ug/ml-gram-negative id/ast or ast only phoenix panels BECTON, DICKINSON & CO. K033558 12/19/2003
bd phoenix automated microbiology system - ceftazidime 0.5-64 ug/ml-gram-negative id/ast or ast only phoenix panels BECTON DICKINSON & CO. K033560 01/14/2004
bd phoenix automated microbiology system - cephalothin (gn) 1-64 ug/ml BECTON, DICKINSON & CO. K031943 08/06/2003
bd phoenix automated microbiology system - confirmatory esbl test BECTON, DICKINSON & CO. K033458 05/28/2004
bd phoenix automated microbiology system - erythromycin 0.0625-8 ug/ml BECTON DICKINSON & CO. K033784 02/03/2004

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