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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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abbott realtime ct/ng and abbott multi-collect specimen collection kit, models 8l07-91, 9k12-03 ABBOTT MOLECULAR, INC. K092704 05/28/2010
abbott realtime ct/ng assay and multi-collect specimen collection kit ABBOTT MOLECULAR, INC. K080739 07/10/2008
abbott tdm multiconstituent calibrator, thermo scientific qms multi-constituent calibrators Microgenics Corporation K120936 12/13/2012
abl 80 co-ox system SENDX MEDICAL, INC. K080370 07/31/2008
abl80 flex analyzer SENDX MEDICAL, INC. K051804 11/01/2005
abl80 flex and abl80 flex co-ox SENDX MEDICAL INC K151639 12/07/2015
abl80 flex co-ox with aqure connectivity SENDX MEDICAL INC. K151856 08/06/2015
abl800 flex RADIOMETER MEDICAL APS K041874 10/08/2004
abl800 flex with aqure connectivity Radiometer Medical Aps. K142898 06/17/2015
abl800 flex with flexq module, model abl8xx RADIOMETER MEDICAL APS K043218 05/10/2005

*   The maximium 500 devices meeting your search criteria returned. Please narrow your search.
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