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CHH — Enzymatic Esterase--Oxidase, Cholesterol Class I

FDA Device Classification

Classification Details

Product Code
CHH
Device Class
Class I
Regulation Number
862.1175
Submission Type
Review Panel
CH
Medical Specialty
Clinical Chemistry
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K251091truvian healthLipidsDecember 30, 2025
K232404medicon hellasCHOLESTEROL; HDL-cholesterol ; LDL-cholesterol; TRIGLYCERIDESAugust 9, 2024
K203597abbott ireland diagnostics divisionCholesterol2June 30, 2022
K190490ortho-clinical diagnosticsVITROS XT Chemistry Products TRIG-CHOL SlidesMarch 27, 2019
K181373laboratory corporation of america holdingsExtended Lipid Panel AssayOctober 18, 2018
K180504acon laboratoriesMission Lipid Panel Monitoring SystemMarch 28, 2018
K163406acon laboratoriesMission Cholesterol Monitoring System, Mission Cholesterol Pro Monitoring SystemJuly 11, 2017
K151545polymer technology systemsCardioChek Plus Test System, CardioChek Home Test System, CardioChek PA Test SysDecember 22, 2016
K150654randox laboratoriesCholesterolSeptember 29, 2015
K132031axis-shield pocAFINION LIPID PANEL AND AFINION LIPID PANEL CONTROLMarch 21, 2014
K130200abaxisPICCOLO TOTAL CHOLESTEROL - CAPILLARY TEST SYSTEMFebruary 15, 2013
K122757alfa wassermann diagnostic technologiesACE CHOLESTEROL REAGENT, ACE HDL-C REAGENT, ACE LDL-C REAGENT, ACE TRIGLYCERIDESOctober 5, 2012
K120202vital diagnostics ptyEON CHOLESTEROL REAGENTJuly 27, 2012
K113262alfa wassermann diagnostic technologiesACE CHOLESTEROL REAGENT, ACE HDL-C REAGENT, ACE LDL-C REAGENT-C, ACE-TRISLYCERIDJuly 3, 2012
K112538alfa wassermann diagnostic technologiesACE CHOLESTEROL REAGENT, ACE HDL-C REAGENT, ACE LDL-C REAGENT, ACE TRIGLYCERIDESMarch 29, 2012
K111753hitachi chemical diagnosticsHITACHI CLINICAL ANALYZER S TEST REAGENT CATRIDGE FOR: CHOLESTROL, HDL, LDL, ANDDecember 14, 2011
K091413alfa wassermannS-TEST CHOLESTEROL (CHO), MODEL RC0009, S-TEST HDL CHOLESTEROL (HDL), MODEL RC00October 26, 2009
K080623jas diagnosticsCHOLESTEROL OXIDASE JASE, AND GLYCEROL INASE TRIGLYCERIDES, MODEL NANovember 17, 2008
K072249medicaEASYRA CHOLESTEROL REAGENT; EASYRA CALCIUM REAGENT REAGENTFebruary 20, 2008
K071593polymer technology systemsPTS PANELS CHOL+HDL PANEL TEST STRIPSOctober 15, 2007