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

JJY — Predicate Candidate Screening

673 FDA 510(k) clearances under this product code; the 50 most recent screened below.

45 daysmedian FDA review time

129 days90th percentile

673clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K162530	Multichem IA Plus	Techno-Path Manufacturing	2017-03-31	203	0
K163629	Audit MicroControls Linearity FD Tumor Markers II	Aalto Scientific, Ltd.	2017-03-10	78	0
K163015	Liquichek Tumor Marker Control-Level 1; Liquichek Tumor Mark	Bio-Rad Laboratories	2017-01-10	74	0
K153712	VK-3 Verification Kit, VK-4 Verification Kit, VK-R5 Verifica	Radiometer America, Inc.	2016-01-28	35	0
K150300	Liquichek Cardiac Markers Plus Control LT	Bio-Rad Laboratories	2015-12-11	308	0
K142964	VALIDATE Anemia Calibration Verification/ Linearity Test Kit	Maine Standards Company, LLC	2015-04-30	198	0
K143379	Liquichek Maternal Serum II Control	Bio-Rad Laboratories	2015-03-13	108	0
K143573	Audit MicroControls Linearity FD Tumor Markers II	Aalto Scientific, Ltd.	2015-01-16	30	0
K140971	LIQUID ASSAYED CHEMISTRY CONTROL PREMIUM PLUS LEVEL 1,2 AND	Randox Laboratories Limited	2014-12-08	236	1
K142978	Audit MicroControls Linearity LQ Special Diabetes	Aalto Scientific, Ltd.	2014-11-20	36	0
K133676	ABX PENTRA MICRO ALB CONTROL L/H	HORIBA ABX SAS	2014-07-11	224	0
K141073	LIQUICHEK TUMOR MARKER CONTROL	Bio-Rad Laboratories	2014-06-23	59	0
K140522	RANDOX IMMUNOASSAY PREMIUM PLUS CONTROL LEVELS 1,2 AND LEVEL	Randox Laboratories Limited	2014-05-22	79	2
K140916	LIQUICHEK CARDIAC TROPONINS CONTROL, LEVELS 1,2 AND 3, TRILE	Bio-Rad Laboratories	2014-05-06	26	0
K140764	LIQUICHEK IMMUNOLOGYCONTROL-LEVEL 1,LEVEL 2, LEVEL 3, MINIPA	Bio-Rad Laboratories	2014-04-25	29	0
K134013	LYPHOCHEK ALLERGEN SIGE CONTROL, NEGATIVE, LYPOCHEK ALLERGEN	Bio-Rad Laboratories	2014-04-24	115	0
K140393	RANDOX AMMONIA ETHANOL CONTROL LEVELS 1, 2 AND LEVEL 3	Randox Laboratories Limited	2014-03-25	39	0
K133960	LYPOCHEK SPECIALTY IMMUNOASSAY CONTROL	Bio-Rad Laboratories	2014-01-22	29	0
K132227	LIQUICHEK IMMUNOASSAY PREMIUM CONTROL-TRILEVEL, LIQUICHEK IM	Bio-Rad Laboratories	2013-10-25	100	0
K132156	RANDOX CSF CONTROLS LEVELS 2 AND 3	Randox Laboratories, Ltd.	2013-10-23	104	0
K132751	MULTICHEM S PLUS / S PLUS (ASSAYED)	Techno-Path Manufacturing , Ltd.	2013-10-22	49	0
K131993	MULTICHEM U	Techno-Path Manufacturing , Ltd.	2013-10-15	109	0
K131479	V8 SP NORMAL CONTROL, ABNORMAL CONTROL	Helena Laboratories	2013-10-07	138	0
K131992	MULTICHEM P	Techno-Path Manufacturing , Ltd.	2013-09-25	89	0
K132091	MULTICHEM IA AND IA PLUS	Techno-Path Manufacturing , Ltd.	2013-09-20	74	0
K131595	EUROTROL GAS-ISE HCT QC AND EUROTROL GAS-ISE HCT LVM	Eurotrol B.V.	2013-07-26	53	0
K130337	RANDOX SPECIALITY CONTROL (I) LEVELS 1, 2 AND 3	Randox Laboratories Limited	2013-06-19	128	0
K130963	LIQUICHEK PEDIATRIC CONTROL, LEVEL 1; LIQUICHEK PEDIATRIC CO	Bio-Rad Laboratories, Inc.	2013-05-06	28	0
K130762	AUDIT MICROCV THERAPEUTIC DRUG (TDM) LINEARITY SET	Aalto Scientific, Ltd.	2013-04-29	40	0
K124009	MISSION CLINICHECK ASSAYED CHEMISTRY CONTROLS, LEVEL 1, MISS	Diamond Diagnostics, Inc.	2013-04-17	111	0
K130761	LIQUICHEK IMMUNOLOGY CONTROL, LEVEL 1,2,3, TRILEVEL MINIPAK	Bio-Rad Laboratories	2013-04-12	23	0
K123725	FASTPACK CONTROL KIT	Qualigen, Inc.	2013-03-08	94	0
K130162	LIQUID ASSAYED MULTIQUAL PREMIUM	Bio-Rad Laboratories	2013-03-01	37	0
K123775	LIQUICHEK SPINAL FLUID CONTROL LEVEL 1, LIQUICHEK SPINAL FLU	Bio-Rad Laboratories	2013-01-31	52	0
K123663	LIQUIDCHEK CARDIAC MARKERS PLUS CONTROL LT; LEVEL 1C, LEVEL	Bio-Rad Laboratories	2012-12-27	29	0
K121603	RANDOX IMMUNOASSAY SPECIALITY CONTROL (II), LEVEL 1, LEVEL 2	Randox Laboratories, Ltd.	2012-11-20	228	0
K123198	LIQUICHEK ETHANOL/AMMONIA CONTROL LEVEL 1 MODEL 271, LIQUICH	Bio-Rad Laboratories	2012-11-20	40	0
K122838	LIQUICKEK IMMUNOASSAY PLUS CONTROL, LEVEL 1 MODEL 267, LIQUI	Bio-Rad Laboratories	2012-10-17	30	0
K113720	RANDOX MATERNAL CONTROL, LEVELS 1, 2 AND 3	Randox Laboratories, Ltd.	2012-09-20	276	0
K122291	THERMO SCIENTIFIC MAS OMNI-CARDIO	Microgenics Corporation	2012-08-31	31	0
K121759	CONE-TROL LIQUID CHEMISTRY CONTROLS	Cone Bioproducts	2012-07-24	39	0
K121794	LIQUICHEK URINE CHEMISTRY CONTROL	Bio-Rad, Diagnostics Grp.	2012-07-11	22	0
K121468	EUROTROL GAS-ISE METABOLITES	Eurotrol B.V.	2012-06-22	36	0
K112742	AUDIT MICROLQ SPINAL FLUID CONTROL	Aalto Scientific, Ltd.	2012-06-15	268	0
K111964	AUDIT MICROCV URINE/FLUIDS CHEMISTRY LINEARITY	Aalto Scientific, Ltd.	2012-03-02	235	0
K112705	AUDIT(R) MICROLQ(TM) SERUM PROTEIN CONTROL	Aalto Scientific, Ltd.	2012-01-24	130	0
K110534	RANDOX LIQUID CARDIAC CONTROL LEVELS 1, 2 AND 3	Randox Laboratories Limited	2012-01-23	332	0
K112337	RANDOX LIQUID IMMUNOASSAY PREMIUM CONTROLS, LEVEL 1, LEVEL2,	Randox Laboratories, Ltd.	2011-12-01	108	0
K101863	IT/IF CONTROL	Sebia	2011-11-07	493	0
K110738	THERMO SCIENTIFIC MAS OMNI-CORE	Microgenics Corporation	2011-11-03	231	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