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LBS — Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl Class I

FDA Device Classification

Classification Details

Product Code
LBS
Device Class
Class I
Regulation Number
862.1475
Submission Type
Review Panel
CH
Medical Specialty
Clinical Chemistry
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K162593roche diagnostics operations (rdo)HDL-Cholesterol Gen.4October 19, 2016
K153435randox laboratoriesDirect HDL Cholesterol (HDL)January 8, 2016
K132711carolina liquid chemistriesCAROLINA LIQUID CHEMISTRIES HDL CHOLESTEROL REAGENTMay 8, 2014
K120609ortho-clinical diagnosticsVITROS CHEMISTRY PRODUCTS DHDL SLIDESSeptember 7, 2012
K111516liposcienceNMR LIPOPROFILE (R) TEST AND NMR PROFILERSeptember 27, 2011
K103747elitechgroup seppimELITECH CLINCAL SYSTEMS CHOLESTEROL HDL SL 2G, HDL 2G CALIBRATOR, LDL SL 2G, LDLAugust 31, 2011
K111036medica corporationEASYRA HDL REAGENT; EASYRA LDL REAGENT; EASYRA CHOL REAGENT; EASYRA TRIG REAGENTJuly 12, 2011
K100550polymedcoPOLY-CHEM 90 DIRECT HDL CHOLESTEROL, POLY-CHEM 90 DIRECT LDL CHOLESTEROL, POLY-CSeptember 28, 2010
K100010beckman coulterHDL CHOLESTEROL (HDLX) ASSAYMay 14, 2010
K080125wako chemicals usaAPOLOWAKO T-CHO, HDL-C, TG AND ANALYZER, MODELS 993-23501, 999-23601, 995-23701 July 18, 2008
K073497medicaHDL CHOLESTEROL REAGENT, MODEL 10211April 14, 2008
K072395diazyme laboratoriesDIAZYME HDL-CHOLESTEROL REAGENT,CALIBRATOR, CONTROLSJanuary 3, 2008
K072836accutechCHOLESTRAK HDL CHOLESTEROL HOME TESTDecember 27, 2007
K071706clinical dataENVOY 500 HDL; CHOLESTEROL REAGENT KIT (MODEL# 55301), CALIBRATOR KIT (MODEL# 55December 20, 2007
K062092premdPREVU POINT OF CARE SKIN STEROL TESTSeptember 15, 2006
K053157dade behringAUTOMATED HDL CHOLESTEROL FLEX REAGENT CARTRIDGE, MODEL DF48ADecember 9, 2005
K051962abbott laboratoriesULTRA HDLAugust 25, 2005
K050632bayer healthcareADVIA IMS DIRECT HDL CHOLESTEROL ASSAYMay 26, 2005
K041928diagnostic chemicalsHDL-ADVANCE ASSAY, CAT. NO. 278-20, 278-50A, 278-50BNovember 23, 2004
K041090denka seiken coHDL-EX SEIKEN ASSAY KITOctober 29, 2004