Product code JJY

Device name: Multi-Analyte Controls, All Kinds (Assayed)
Medical specialty: Clinical Chemistry
Device class: 1
Regulation number: 862.1660
Review panel: CH
Implant: N
Life sustaining/supporting: N
GMP exempt: N
Third party review: N
Summary malfunction reporting: Eligible
Source: FDA openFDA device classification dataset

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K162530	Multichem IA Plus	Techno-Path Manufacturing	2017-03-31
K163629	Audit MicroControls Linearity FD Tumor Markers II	Aalto Scientific, Ltd.	2017-03-10
K163015	Liquichek Tumor Marker Control-Level 1; Liquichek Tumor Marker Control-Level 2; Liquichek Tumor Marker Control-Level 3; Liquichek Tumor Marker Control- Trilevel MiniPak	Bio-Rad Laboratories	2017-01-10
K153712	VK-3 Verification Kit, VK-4 Verification Kit, VK-R5 Verification Kit, VK-R7 Verification Kit, VK-Crea Verification Kit	Radiometer America, Inc.	2016-01-28
K150300	Liquichek Cardiac Markers Plus Control LT	Bio-Rad Laboratories	2015-12-11
K142964	VALIDATE Anemia Calibration Verification/ Linearity Test Kit	Maine Standards Company, LLC	2015-04-30
K143379	Liquichek Maternal Serum II Control	Bio-Rad Laboratories	2015-03-13
K143573	Audit MicroControls Linearity FD Tumor Markers II	Aalto Scientific, Ltd.	2015-01-16
K140971	LIQUID ASSAYED CHEMISTRY CONTROL PREMIUM PLUS LEVEL 1,2 AND LEVEL 3.	Randox Laboratories Limited	2014-12-08
K142978	Audit MicroControls Linearity LQ Special Diabetes	Aalto Scientific, Ltd.	2014-11-20
K133676	ABX PENTRA MICRO ALB CONTROL L/H	HORIBA ABX SAS	2014-07-11
K141073	LIQUICHEK TUMOR MARKER CONTROL	Bio-Rad Laboratories	2014-06-23
K140522	RANDOX IMMUNOASSAY PREMIUM PLUS CONTROL LEVELS 1,2 AND LEVEL 3 AND IMMUNOASSAY PREMIUM PLUS TRI-LEVEL CONTROL	Randox Laboratories Limited	2014-05-22
K140916	LIQUICHEK CARDIAC TROPONINS CONTROL, LEVELS 1,2 AND 3, TRILEVEL/MINIPAK	Bio-Rad Laboratories	2014-05-06
K140764	LIQUICHEK IMMUNOLOGYCONTROL-LEVEL 1,LEVEL 2, LEVEL 3, MINIPAK	Bio-Rad Laboratories	2014-04-25
K134013	LYPHOCHEK ALLERGEN SIGE CONTROL, NEGATIVE, LYPOCHEK ALLERGEN SIGE CONTROL, NEGATIVE MINIPAK, LYPHOCHEK ALLERGEN SIGE CO	Bio-Rad Laboratories	2014-04-24
K140393	RANDOX AMMONIA ETHANOL CONTROL LEVELS 1, 2 AND LEVEL 3	Randox Laboratories Limited	2014-03-25
K133960	LYPOCHEK SPECIALTY IMMUNOASSAY CONTROL	Bio-Rad Laboratories	2014-01-22
K132227	LIQUICHEK IMMUNOASSAY PREMIUM CONTROL-TRILEVEL, LIQUICHEK IMMUNOASSAY PREMIUM CONTROL-LEVEL I, LIQUICHEK IMMUNOASSAY	Bio-Rad Laboratories	2013-10-25
K132156	RANDOX CSF CONTROLS LEVELS 2 AND 3	Randox Laboratories, Ltd.	2013-10-23
K132751	MULTICHEM S PLUS / S PLUS (ASSAYED)	Techno-Path Manufacturing , Ltd.	2013-10-22
K131993	MULTICHEM U	Techno-Path Manufacturing , Ltd.	2013-10-15
K131479	V8 SP NORMAL CONTROL, ABNORMAL CONTROL	Helena Laboratories	2013-10-07
K131992	MULTICHEM P	Techno-Path Manufacturing , Ltd.	2013-09-25
K132091	MULTICHEM IA AND IA PLUS	Techno-Path Manufacturing , Ltd.	2013-09-20
K131595	EUROTROL GAS-ISE HCT QC AND EUROTROL GAS-ISE HCT LVM	Eurotrol B.V.	2013-07-26
K130337	RANDOX SPECIALITY CONTROL (I) LEVELS 1, 2 AND 3	Randox Laboratories Limited	2013-06-19
K130963	LIQUICHEK PEDIATRIC CONTROL, LEVEL 1; LIQUICHEK PEDIATRIC CONTOL, LEVEL 2; LIQUICHEK PEDIATRIC CONTROL, BILEVEL MINIPAK	Bio-Rad Laboratories, Inc.	2013-05-06
K130762	AUDIT MICROCV THERAPEUTIC DRUG (TDM) LINEARITY SET	Aalto Scientific, Ltd.	2013-04-29
K124009	MISSION CLINICHECK ASSAYED CHEMISTRY CONTROLS, LEVEL 1, MISSION CLINICHECK ASSAYED CHEMISTRY CONTROLS LEVEL 2, MISSION C	Diamond Diagnostics, Inc.	2013-04-17

Primary DI, Brand, Company table
Primary DI	Brand	Company	Published
05391523442848	Multichem AE	TECHNO-PATH MANUFACTURING LIMITED	2026-06-02
05391523442855	Multichem AE	TECHNO-PATH MANUFACTURING LIMITED	2026-06-02
05391523442862	Multichem IA Speciality	TECHNO-PATH MANUFACTURING LIMITED	2026-06-02
05391523442879	Multichem IA Speciality	TECHNO-PATH MANUFACTURING LIMITED	2026-06-02
05391523442886	Multichem IA Speciality	TECHNO-PATH MANUFACTURING LIMITED	2026-06-02
05391523442893	Multichem CSF	TECHNO-PATH MANUFACTURING LIMITED	2026-06-02
05391523442909	Multichem CSF	TECHNO-PATH MANUFACTURING LIMITED	2026-06-02
05391523442916	Multichem NB	TECHNO-PATH MANUFACTURING LIMITED	2026-06-02
05391523442923	Multichem D-Dimer	TECHNO-PATH MANUFACTURING LIMITED	2026-06-02
05391523442930	Multichem D-Dimer	TECHNO-PATH MANUFACTURING LIMITED	2026-06-02
05391523442831	Multichem AE	TECHNO-PATH MANUFACTURING LIMITED	2026-06-02
00884883011427	CRP (C-Reactive Protein)	Microgenics Corporation	2026-05-27
00884883011397	MAS Immunology Advanced Level 3	Microgenics Corporation	2026-05-27
00884883011373	MAS Immunology Advanced Level 1	Microgenics Corporation	2026-05-27
00884883009080	MAS Immunology Advanced Sample Pack	Microgenics Corporation	2026-05-27
00884883011380	MAS Immunology Advanced Level 2	Microgenics Corporation	2026-05-27
08430793040525	Aptiva® Celiac Disease IgG Controls	INOVA DIAGNOSTICS, INC.	2022-05-27
08430793040587	Aptiva® Celiac Disease IgA Controls	INOVA DIAGNOSTICS, INC.	2022-05-27
08718734961499	CueSee® VeriSTAT QC	Eurotrol B.V.	2020-10-08
08718734961482	CueSee® VeriSTAT QC	Eurotrol B.V.	2020-10-08
08718734961475	CueSee® VeriSTAT QC	Eurotrol B.V.	2020-10-08
10627966005299	RAMP® Cardiac Controls - Level 1	Response Biomedical Corp	2019-12-20
08718734960805	Eurotrol® epoc® Calibration Verification Fluids	Eurotrol B.V.	2018-07-11
08718734960799	Eurotrol epoc GAS-ISE Metabolites	Eurotrol B.V.	2018-07-11
08718734960775	Eurotrol epoc GAS-ISE Metabolites	Eurotrol B.V.	2018-07-11
08718734960751	Eurotrol epoc GAS-ISE Metabolites	Eurotrol B.V.	2018-07-11
08718734960737	Eurotrol epoc GAS-ISE Metabolites	Eurotrol B.V.	2018-07-11
08718734960874	Eurotrol	Eurotrol B.V.	2017-09-12
08718734960898	Eurotrol	Eurotrol B.V.	2017-09-12
08718734960911	Eurotrol	Eurotrol B.V.	2017-09-12

Product code JJY

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