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Panels › Clinical Chemistry › Product code LBS · Class 1

Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl

Regulation 862.1475

0510(k)s in 12 months (80 all time)
1recalls in 12 months (9 all time)
8recalls that name a 510(k)
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Top companies in LBS

Company510(k)sRecalls
Abbott Laboratories40
Beckman Coulter, Inc.31
Beckman Instruments, Inc.40
Ortho-Clinical Diagnostics, Inc.22
Genzyme Corp.30
Randox Laboratories, Ltd.30
Roche Diagnostics Corp.21
A.P. Total Care, Inc.20
Cholestech Corp.20
Diagnostic Chemicals , Ltd.20
DateFirm and productCodeLinked 510(k)
Jan 21, 2026Beckman Coulter Ireland, Inc.
The LDL-Cholesterol assay is comprised of two distinct phases. In phase one a unique detergent solubilizes cholesterol from non-LDL- lipoprotein particles. This cholesterol is consumed by cholesterol
Open, Classified		 LBSK040471
Apr 3, 2017Beckman Coulter Inc.
HDL Cholesterol Reagent (HDL 2 x 200), Catalog No. A15625. Intended for quantitative determination of HDL cholesterol in the high density lipoprotein fraction of human serum or plasma.
Terminated		 LBSNone listed
Aug 2, 2016Alere San Diego, Inc.
LDX Optical Check Cassettes (OCC) Model Number: 10-228 and 14-535 Cassette in box with foam insert. The cassette is used to check the optics system of the LDX analyzer. Product Usage: The Optics Che
Terminated		 LBSK120615
Mar 17, 2016Siemens Healthcare Diagnostics, Inc.
Advia Chemistry Assay: Direct HDL Cholesterol (D-HDL)
Terminated		 LBSK982341
Jun 27, 2015Roche Diagnostics Operations, Inc.
HDL-Cholesterol plus gen.3.; and Small Supersized Intended for use on COBAS Integra 800 and 400 plus systems, cobas c111, and cobas c systems for the quantitative determination of HDL-cholesterol con
Terminated		 LBSK012286
Jun 27, 2015Roche Diagnostics Operations, Inc.
HDL-Cholesterol gen.3. For the quantitative determination of high-density lipoprotein Cholesterol (HDL-C) in serum and plasma.
Terminated		 LBSK963213
Nov 15, 2013Ortho-Clinical Diagnostics
VITROS Chemistry Products dHDL Slides packaged as 300 slides/pack catalog number 6801895 VITROS dHDL Slides quantitatively measure HDL cholesterol (HDLC) concentration in serum and plasma using VITROS
Terminated		 LBSK042006
K120609
Mar 26, 2012Ortho-Clinical Diagnostics
VITROS Chemistry Products --- dHDL Slides --- Ortho Clinical Diagnostics, a Johnson&Johnson company --- [Mfg Symbol] Ortho-Clinical Diagnostics, Inc., Rochester, NY USA --- VITROS dHDL Slides are used
Terminated		 LBSK042006
Oct 9, 2008Roche Diagnostics Corp.
Roche Diagnostics HDLC3, HDL-Cholesterol Plus 3rd Generation, COBAS INTEGRA, cobas c systems, Roche Diagnostics, Indianapolis, IN.; 04399803190. An in-vitro diagnostic reagent system intended for us
Terminated		 LBSK012286

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