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Randox Laboratories Limited

FDA 510(k) & PMA Approved Devices — 7 products

Total Devices7
Categories4
Latest FDA decision2026-01-23
TypeNumberDevice NameCodeDateActions
510(k) K250741 Evidence MultiSTAT DOA Urine MultiPlexDJG2026-01-23 View
510(k) K220451 Evidence MultiSTAT DOA Urine MultiPlex, Evidence MultiSTATDJG2023-10-05 View
510(k) K221550 Evidence MultiSTAT DOA Urine MultiPlexDJG2023-10-05 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
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