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U.S. Department of Health and Human Services

510(k) Premarket Notification
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1 to 9 of 9 Results
ProductCode: JJY Applicant: RANDOX LABORATORIES, LTD. Decision Date To: 05/29/2024
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randox csf controls levels 2 and 3 RANDOX LABORATORIES, LTD. K132156 10/23/2013
randox immunoassay speciality control (ii), level 1, level 2 and level 3 RANDOX LABORATORIES, LTD. K121603 11/20/2012
randox maternal control, levels 1, 2 and 3 RANDOX LABORATORIES, LTD. K113720 09/20/2012
randox liquid immunoassay premium controls, level 1, level2, level 3 and tri level RANDOX LABORATORIES, LTD. K112337 12/01/2011
randox liquid urine control levels 2 and 3 RANDOX LABORATORIES, LTD. K110904 09/30/2011
randox immunoassay control RANDOX LABORATORIES, LTD. K040379 06/16/2004
randox lipid control RANDOX LABORATORIES, LTD. K022591 08/30/2002
randox assayed specific protein control RANDOX LABORATORIES, LTD. K972608 08/04/1997
precision-multi-sera - human - normal and elevated RANDOX LABORATORIES, LTD. K942458 03/13/1995
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