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Randox Laboratories Limited

FDA 510(k) & PMA Approved Devices — 13 products

Total Devices13
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K250741 Evidence MultiSTAT DOA Urine MultiPlexDJG2026-01-23 View
510(k) K221550 Evidence MultiSTAT DOA Urine MultiPlexDJG2023-10-05 View
510(k) K220451 Evidence MultiSTAT DOA Urine MultiPlex, Evidence MultiSTATDJG2023-10-05 View
510(k) K162275 Randox RX Daytona Plus Alkaline Phosphatase (ALP)CJE2017-04-21 View
510(k) K161691 Direct LDL Cholesterol (LDL)MRR2017-03-20 View
510(k) K152343 Direct BilirubinJFM2016-02-16 View
510(k) K152344 Total BilirubinJFM2016-01-28 View
510(k) K130337 RANDOX SPECIALITY CONTROL (I) LEVELS 1, 2 AND 3JJY2013-06-19 View
510(k) K113747 RANDOX OPIATES ASSAYDJG2012-08-24 View
510(k) K122126 DIRECT LDL/HDL CHOLESTEROL CALIBRATORJIS2012-08-14 View
510(k) K110534 RANDOX LIQUID CARDIAC CONTROL LEVELS 1, 2 AND 3JJY2012-01-23 View
510(k) K110846 RANDOX URINALYSIS CONTROLS, LEVELS 1 AND 2JJW2011-09-30 View
510(k) K041361 RANDOX TRI LEVEL CARDIAC CONTROLJJY2004-09-09 View
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