LBS · Class I · 21 CFR 862.1475

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

Leading manufacturers include Abbott Laboratories, Beckman Instruments, Inc. and Beckman Coulter, Inc..

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 Jan 08, 2016
Direct HDL Cholesterol (HDL)
K153435
Randox Laboratories, Ltd.
Chemistry · 42d
Cleared Sep 07, 2012
VITROS CHEMISTRY PRODUCTS DHDL SLIDES
K120609
Ortho-Clinical Diagnostics, Inc.
Chemistry · 191d
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 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 Feb 08, 2002
OLYMPUS HDL CHOLESTEROL REAGENT
K014015
Olympus America, Inc.
Chemistry · 65d
Cleared Feb 08, 2002
OLYMPUS LDL CHOLESTEROL REAGENT, OLYMPUS LDL CHOLESTEROL CALIBRATOR, OLYMPUS HDL/LDL CHOLESTEROL CONTROL SERA
K014032
Olympus America, Inc.
Chemistry · 64d
Cleared Aug 08, 2001
MODIFICATION TO:COBAS INTEGRA HDL-CHOLESTEROL PLUS 2ND GENERATION
K012286
Roche Diagnostics Corp.
Chemistry · 19d
Cleared Jun 18, 1999
DIRECT HDL-CHOLESTEROL REAGENT
K990581
Kamiya Biomedical Co.
Chemistry · 115d
Cleared Aug 03, 1998
DIRECT HDL
K981224
Abbott Laboratories
Chemistry · 122d
Cleared Jul 30, 1998
DIRECT HDL-CHOLESTROL LIQUID
K982341
Randox Laboratories, Ltd.
Chemistry · 38d
Cleared Jun 11, 1998
HDL
K981580
Abbott Laboratories
Chemistry · 38d
Cleared Jul 22, 1997
EZ HDL CHOLESTEROL REAGENT(PROCEDURE 354)/EZ HDL CALIBRATOR (354-5)
K972041
Sigma Diagnostics, Inc.
Chemistry · 50d

About Product Code LBS - Regulatory Context