Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Randox Laboratories Limited — Predicate Candidate Screening

18 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

186 daysmedian FDA review time

492 days90th percentile

18clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K250741	Evidence MultiSTAT DOA Urine MultiPlex	Randox Laboratories Limited	2026-01-23	318	0
K220451	Evidence MultiSTAT DOA Urine MultiPlex, Evidence MultiSTAT	Randox Laboratories Limited	2023-10-05	595	1
K221550	Evidence MultiSTAT DOA Urine MultiPlex	Randox Laboratories Limited	2023-10-05	492	0
K162275	Randox RX Daytona Plus Alkaline Phosphatase (ALP)	Randox Laboratories Limited	2017-04-21	252	0
K161691	Direct LDL Cholesterol (LDL)	Randox Laboratories Limited	2017-03-20	273	0
K152343	Direct Bilirubin	Randox Laboratories Limited	2016-02-16	181	0
K152344	Total Bilirubin	Randox Laboratories Limited	2016-01-28	162	1
K150819	Triglycerides	Randox Laboratories Limited	2015-08-06	132	0
K140971	LIQUID ASSAYED CHEMISTRY CONTROL PREMIUM PLUS LEVEL 1,2 AND	Randox Laboratories Limited	2014-12-08	236	1
K142181	RANDOX ALDOLASE CALIBRATION SERUM	Randox Laboratories Limited	2014-09-18	41	0
K140522	RANDOX IMMUNOASSAY PREMIUM PLUS CONTROL LEVELS 1,2 AND LEVEL	Randox Laboratories Limited	2014-05-22	79	2
K140393	RANDOX AMMONIA ETHANOL CONTROL LEVELS 1, 2 AND LEVEL 3	Randox Laboratories Limited	2014-03-25	39	0
K130337	RANDOX SPECIALITY CONTROL (I) LEVELS 1, 2 AND 3	Randox Laboratories Limited	2013-06-19	128	0
K113747	RANDOX OPIATES ASSAY	Randox Laboratories Limited	2012-08-24	248	0
K122126	DIRECT LDL/HDL CHOLESTEROL CALIBRATOR	Randox Laboratories Limited	2012-08-14	27	0
K110534	RANDOX LIQUID CARDIAC CONTROL LEVELS 1, 2 AND 3	Randox Laboratories Limited	2012-01-23	332	0
K110846	RANDOX URINALYSIS CONTROLS, LEVELS 1 AND 2	Randox Laboratories Limited	2011-09-30	186	0
K041361	RANDOX TRI LEVEL CARDIAC CONTROL	Randox Laboratories Limited	2004-09-09	111	0

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda