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JJY — Multi-Analyte Controls, All Kinds (Assayed) Class I

FDA Device Classification

Classification Details

Product Code
JJY
Device Class
Class I
Regulation Number
862.1660
Submission Type
Review Panel
CH
Medical Specialty
Clinical Chemistry
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K162530techno-path manufacturingMultichem IA PlusMarch 31, 2017
K163629aalto scientificAudit MicroControls Linearity FD Tumor Markers IIMarch 10, 2017
K163015bio-rad laboratoriesLiquichek Tumor Marker Control-Level 1; Liquichek Tumor Marker Control-Level 2; January 10, 2017
K153712radiometer americaVK-3 Verification Kit, VK-4 Verification Kit, VK-R5 Verification Kit, VK-R7 VeriJanuary 28, 2016
K150300bio-rad laboratoriesLiquichek Cardiac Markers Plus Control LTDecember 11, 2015
K142964maine standards companyVALIDATE Anemia Calibration Verification/ Linearity Test KitApril 30, 2015
K143379bio-rad laboratoriesLiquichek Maternal Serum II ControlMarch 13, 2015
K143573aalto scientificAudit MicroControls Linearity FD Tumor Markers IIJanuary 16, 2015
K140971randox laboratories limitedLIQUID ASSAYED CHEMISTRY CONTROL PREMIUM PLUS LEVEL 1,2 AND LEVEL 3.December 8, 2014
K142978aalto scientificAudit MicroControls Linearity LQ Special DiabetesNovember 20, 2014
K133676horiba abxABX PENTRA MICRO ALB CONTROL L/HJuly 11, 2014
K141073bio-rad laboratoriesLIQUICHEK TUMOR MARKER CONTROLJune 23, 2014
K140522randox laboratories limitedRANDOX IMMUNOASSAY PREMIUM PLUS CONTROL LEVELS 1,2 AND LEVEL 3 AND IMMUNOASSAY PMay 22, 2014
K140916bio-rad laboratoriesLIQUICHEK CARDIAC TROPONINS CONTROL, LEVELS 1,2 AND 3, TRILEVEL/MINIPAKMay 6, 2014
K140764bio-rad laboratoriesLIQUICHEK IMMUNOLOGYCONTROL-LEVEL 1,LEVEL 2, LEVEL 3, MINIPAKApril 25, 2014
K134013bio-rad laboratoriesLYPHOCHEK ALLERGEN SIGE CONTROL, NEGATIVE, LYPOCHEK ALLERGEN SIGE CONTROL, NEGAApril 24, 2014
K140393randox laboratories limitedRANDOX AMMONIA ETHANOL CONTROL LEVELS 1, 2 AND LEVEL 3March 25, 2014
K133960bio-rad laboratoriesLYPOCHEK SPECIALTY IMMUNOASSAY CONTROLJanuary 22, 2014
K132227bio-rad laboratoriesLIQUICHEK IMMUNOASSAY PREMIUM CONTROL-TRILEVEL, LIQUICHEK IMMUNOASSAY PREMIUM COOctober 25, 2013
K132156randox laboratoriesRANDOX CSF CONTROLS LEVELS 2 AND 3October 23, 2013