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U.S. Department of Health and Human Services

510(k) Premarket Notification
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1 to 10 of 87 Results
ProductCode: LON Applicant: BIOMERIEUX, INC. Decision Date To: 03/24/2023
 
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vitek2 ast-gram negative delafloxacin (<=0.06->=4 ug/ml) bioMerieux, Inc. K183524 03/12/2019
vitek(r) 2 streptococcus tetracycline BIOMERIEUX, INC. K111893 02/28/2012
vitek(r) 2 streptococcus clindamycin BIOMERIEUX, INC. K112129 09/27/2011
vitek gram positive susceptibility daptomycin BIOMERIEUX, INC. K052656 11/07/2005
vitek gram positive susceptibility (gps) card for rifampin BIOMERIEUX, INC. K042946 12/07/2004
vitek gram positive susceptibility (gps) card for linezolid BIOMERIEUX, INC. K022045 08/15/2002
vitek gram positive susceptibility (gps) card for ertapenem BIOMERIEUX, INC. K042963 12/13/2004
vitek gram negative susceptibility (gns) card for moxifloxacin BIOMERIEUX, INC. K043237 12/23/2004
vitek gram negative susceptibility (gns) card for ertapenem BIOMERIEUX, INC. K043230 12/30/2004
vitek gram negative gatifloxacin BIOMERIEUX, INC. K032711 10/31/2003
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