LBS · Class I · 21 CFR 862.1475

FDA Product Code LBS: Ldl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl

Leading manufacturers include Beckman Instruments, Inc., Abbott Laboratories and Genzyme Corp..

80
Total
80
Cleared
84d
Avg days
1979
Since

FDA 510(k) Cleared Ldl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl Devices (Product Code LBS)

80 devices
1–24 of 80
Cleared Oct 19, 2016
HDL-Cholesterol Gen.4
K162593
Roche Diagnostics Operations (Rdo)
Chemistry · 33d
Cleared Jan 08, 2016
Direct HDL Cholesterol (HDL)
K153435
Randox Laboratories, Ltd.
Chemistry · 42d
Cleared May 08, 2014
CAROLINA LIQUID CHEMISTRIES HDL CHOLESTEROL REAGENT
K132711
Carolina Liquid Chemistries Corp.
Chemistry · 252d
Cleared Sep 07, 2012
VITROS CHEMISTRY PRODUCTS DHDL SLIDES
K120609
Ortho-Clinical Diagnostics, Inc.
Chemistry · 191d
Cleared Sep 27, 2011
NMR LIPOPROFILE (R) TEST AND NMR PROFILER
K111516
Liposcience, Inc.
Chemistry · 118d
Cleared Aug 31, 2011
ELITECH CLINCAL SYSTEMS CHOLESTEROL HDL SL 2G, HDL 2G CALIBRATOR, LDL SL 2G, LDL 2G CALIBRATOR, ELITROL II & ELITECH SYS
K103747
Elitechgroup Seppim S.A.S.
Chemistry · 251d
Cleared Jul 12, 2011
EASYRA HDL REAGENT
K111036
Medica Corporation
Chemistry · 89d
Cleared Sep 28, 2010
POLY-CHEM 90 DIRECT HDL CHOLESTEROL, POLY-CHEM 90 DIRECT LDL CHOLESTEROL, POLY-CHEM 90 CHOLESTEROL, POLY-CHEM 90 TRIGLYC
K100550
Polymedco, Inc.
Chemistry · 214d
Cleared May 14, 2010
HDL CHOLESTEROL (HDLX) ASSAY
K100010
Beckman Coulter, Inc.
Chemistry · 130d
Cleared Jul 18, 2008
APOLOWAKO T-CHO, HDL-C, TG AND ANALYZER, MODELS 993-23501, 999-23601, 995-23701 AND 993-25201
K080125
Wako Chemicals USA, Inc.
Chemistry · 183d
Cleared Apr 14, 2008
HDL CHOLESTEROL REAGENT, MODEL 10211
K073497
Medica Corp.
Chemistry · 123d
Cleared Jan 03, 2008
DIAZYME HDL-CHOLESTEROL REAGENT,CALIBRATOR, CONTROLS
K072395
Diazyme Laboratories
Chemistry · 129d
Cleared Dec 20, 2007
ENVOY 500 HDL
K071706
Clinical Data, Inc.
Chemistry · 182d
Cleared Dec 09, 2005
AUTOMATED HDL CHOLESTEROL FLEX REAGENT CARTRIDGE, MODEL DF48A
K053157
Dade Behring, Inc.
Chemistry · 25d
Cleared Aug 25, 2005
ULTRA HDL
K051962
Abbott Laboratories
Chemistry · 37d
Cleared May 26, 2005
ADVIA IMS DIRECT HDL CHOLESTEROL ASSAY
K050632
Bayer Healthcare, LLC
Chemistry · 78d
Cleared Nov 23, 2004
HDL-ADVANCE ASSAY, CAT. NO. 278-20, 278-50A, 278-50B
K041928
Diagnostic Chemicals , Ltd.
Chemistry · 127d
Cleared Oct 29, 2004
HDL-EX SEIKEN ASSAY KIT
K041090
Denka Seiken Co., Ltd.
Chemistry · 186d
Cleared Oct 28, 2004
VITROS CHEMISTRY PRODUCTS DHDL SLIDES, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 25, VITROS CHEMISTRY PRODUCTS PERFORMACE
K042006
Ortho-Clinical Diagnostics, Inc.
Chemistry · 94d
Cleared Sep 16, 2004
SYNCHRON SYSTEMS HDL CHOLESTEROL (HDL), SYNCHRON SYSTEMS LIPID PLUS CALIBRATORS 1 & 2, MODELS A15625/A16747
K042195
Beckman Coulter, Inc.
Chemistry · 34d
Cleared Jun 07, 2004
SYNCHRON SYSTEMS HDL CHOLESTEROL (HDLD) REAGENT
K040767
Beckman Coulter, Inc.
Chemistry · 74d
Cleared Mar 10, 2004
DIRECT HDL-CHOLESTEROL LIQUID COLOR
K032932
Stanbio Laboratory
Chemistry · 170d
Cleared Dec 05, 2003
HDL-CHOLESTEROL PLUS 2ND GENERATION
K033610
Roche Diagnostics Corp.
Chemistry · 18d
Cleared Jan 24, 2003
PICCOLO HDL TEST SYSTEM
K023640
Abaxis, Inc.
Chemistry · 86d

About Product Code LBS - Regulatory Context