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U.S. Department of Health and Human Services

510(k) Premarket Notification

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41 to 50 of 500 Results *
Decision Date From: 8/1/2003 Decision Date To: 04/23/2024 In Vitro Products: Yes
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510(K)
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abbott axsym troponin-i adv ABBOTT LABORATORIES K041811 09/10/2004
abbott axsym troponin-i adv ABBOTT LABORATORIES K060875 06/14/2006
abbott carbamazepine assay Microgenics Corporation K123518 06/05/2013
abbott immunoassay/clinical chemistry single analyte quality control materials (assayed) and abbott estradiol calibrator ABBOTT LABORATORIES K041687 08/18/2004
abbott imx sirolimus microparticle enzyme immunoassay AXIS-SHIELD LTD. K042411 04/07/2005
abbott lipid multi constituent calibrator ABBOTT LABORATORIES K123372 01/14/2013
abbott m2000sp and abbott m2000rt, models 9k14-01 (g-series), 9k14-02 (e-series), 9k1501 ABBOTT MOLECULAR, INC. K092705 05/28/2010
abbott multi-collect specimen collection kit, abbott real time ct/ng ABBOTT MOLECULAR, INC. K140354 05/09/2014
abbott phenobarbital assay MICROGENICS CORP. K123271 04/26/2013
abbott plex-id flu assay ABBOTT LABORATORIES K121003 12/21/2012

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