ClearanceBrief
Panels › Clinical Chemistry › Product code CHH · Class 1

Enzymatic Esterase--Oxidase, Cholesterol

Regulation 862.1175

1510(k)s in 12 months (230 all time)
1recalls in 12 months (23 all time)
19recalls that name a 510(k)
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Top companies in CHH

DateFirm and productCodeLinked 510(k)
May 6, 2026DFI Co., Ltd.
QUCARE Total Cholesterol in vitro diagnostic test REF: 6407
Open, Classified
CHHNone listed
Jun 22, 2022Randox Laboratories Ltd.
Randox Cholesterol- For the quantitative in vitro determination of Cholesterol in serum and plasma. Catalog Number: CH2O0
Terminated
CHHK923504
Nov 10, 2021Beckman Coulter Inc.
SYNCHRON Systems Cholesterol (CHOL) Reagent, REF: 467825
Open, Classified
CHHK971505
Nov 1, 2021Randox Laboratories Ltd.
RANDOX CHOL-cholesterol (total) test system intended to measure cholesterol in plasma and serum REF: CH200
Terminated
CHHK923504
Jun 7, 2019Polymer Technology Systems, Inc.
Henry Schein Panels Lipid Panel test strip: IVD Lipid Panel Test Strips Ref Number: 570-0414 Product Usage: PTS Panels Lipid Panel test strips measure total cholesterol, HDL (high density lipoprote
Terminated
CHHK151545
Jun 7, 2019Polymer Technology Systems, Inc.
PTS Panels Lipid Panel test strip: IVD Lipid Panel Test Strips Ref Number: 1710 Product Usage: PTS Panels Lipid Panel test strips measure total cholesterol, HDL (high density lipoprotein) cholester
Terminated
CHHK151545
Jan 16, 2019Polymer Technology Systems, Inc.
Lipid Panel test strips (as a component of smart bundles), REF 2729, also private labeled under Henry Schein as REF 570-0412
Terminated
CHHK023558
Jan 16, 2019Polymer Technology Systems, Inc.
Lipid Panel test strips, REF 1710, also private labeled under Henry Schein as REF 570-0414
Terminated
CHHK013173
Apr 3, 2017Beckman Coulter Inc.
Cholesterol Reagent(CHOL 2 x 300), Catalog No. 467825 Intended for quantitative determination of cholesterol concentration in human serum or plasma.
Terminated
CHHNone listed
Dec 29, 2016Sterling Diagnostics, Inc.
Enzymatic Cholesterol (Trinder/COD-CEH) for IN VITRO DIAGNOSTIC USE in the quantitative determination of analytes. These are CONSUMABLES - a customer buys another when kit is consumed.
Terminated
CHHNone listed
Apr 13, 2016Beckman Coulter Inc.
Cholesterol, Catalog No. OSR6x16 Product Usage:Cholesterol OSR6x16 is intended as a System reagent for the quantitative determination of Cholesterol concentrations in human serum on Beckman Coulter A
Terminated
CHHNone listed
Mar 17, 2016Siemens Healthcare Diagnostics, Inc.
Advia Chemistry Assays - Cholesterol_2 concentrated and Cholesterol, LDL Cholesterol
Terminated
CHHK023504
Feb 2, 2016Horiba Instruments Inc
The ABX PENTRA Cholesterol CP ref. A11A01634 is an in vitro diagnostic assay for quantitative determination of cholesterol in human serum and plasma based on an enzymatic photometric test (Trinders re
Terminated
CHHK060854
Jun 27, 2015Roche Diagnostics Operations, Inc.
Cholesterol Gen.2. The cassette COBAS Integra Cholesterol Gen.2 (CHOL2) contains an in vitro diagnostic reagent system intended for use on COBAS Integra 800 and 400 plus systems, cobas c111, and coba
Terminated
CHHK031824
Jun 27, 2015Roche Diagnostics Operations, Inc.
Cholesterol CHOD-PAP. In vitro diagnostic reagent system intended for use on the Hitachi systems for The quantitative determination of total cholesterol in serum and plasma.
Terminated
CHHK952127
Jan 28, 2015Beckman Coulter Inc.
Beckman Coulter, Cholesterol Assay, Catalog No. OSR6X16
Terminated
CHHK925603
Nov 15, 2013Ortho-Clinical Diagnostics
VITROS Chemistry Products CHOL Slides packaged as 300 slides/pack catalog number 1669829 VITROS CHOL Slides quantitatively measure cholesterol (CHOL) concentration in serum and plasma using VITROS 25
Terminated
CHHK012593
K820263
Feb 6, 2012Alere San Diego
Alere Cholestech LDX Analyzer, Model Number: 10-004, 14-874, 14-875, in vitro diagnostic.
Terminated
CHHK901900
Dec 16, 2010Diagnostic Chemicals, Ltd.
Genzyme Diagnostics Total Serum Cholesterol Kit, IVD Catalog Number: 225-26 Intended use: For the IN VITRO quantitative measurement of total serum cholesterol in serum.
Terminated
CHHK842160
Apr 2, 2010Polymer Technology Systems, Inc.
PTS Panels CHOL+HDL Panel test strips for professional use with CardioChek P-A analyzer, Manufactured by Polymer Technology Systems, Inc., Indianapolis, IN.Catalog # 1795. The product is used to meas
Terminated
CHHK071593
Mar 15, 2010Polymer Technology Systems, Inc.
PTS Panels Lipids Panel test strips for self-testing or professional use with CardioChek P-A analyzers, Manufactured by Polymer Technology Systems, Inc. Catalog # 1710.
Terminated
CHHK022898
K023558
Mar 1, 2010Polymer Technology Systems, Inc.
PTS Panels Cholesterol test strips for self-testing or professional use with CardioChek analyzers, Manufactured by Polymer Technology Systems, Inc., Indianapolis, IN.Catalog # 1711. Intended to provi
Terminated
CHHK981493
K990688
Dec 31, 2002Elan Diagnostics, Inc.
Elan Diagnostics CHO ATAC Cholesterol Reagent Kit Product Number: 516-250
Terminated
CHHK880237

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