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)
Top companies in CHH
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 6, 2026 | DFI Co., Ltd. QUCARE Total Cholesterol in vitro diagnostic test
REF: 6407 Open, Classified |
CHH | None listed |
| Jun 22, 2022 | Randox Laboratories Ltd. Randox Cholesterol- For the quantitative in vitro determination of Cholesterol in serum and plasma.
Catalog Number: CH2O0 Terminated |
CHH | K923504 |
| Nov 10, 2021 | Beckman Coulter Inc. SYNCHRON Systems Cholesterol (CHOL) Reagent, REF: 467825 Open, Classified |
CHH | K971505 |
| Nov 1, 2021 | Randox Laboratories Ltd. RANDOX CHOL-cholesterol (total) test system intended to measure cholesterol in plasma and serum
REF: CH200 Terminated |
CHH | K923504 |
| Jun 7, 2019 | Polymer 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 |
CHH | K151545 |
| Jun 7, 2019 | Polymer 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 |
CHH | K151545 |
| Jan 16, 2019 | Polymer 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 |
CHH | K023558 |
| Jan 16, 2019 | Polymer Technology Systems, Inc. Lipid Panel test strips, REF 1710, also private labeled under Henry Schein as REF 570-0414 Terminated |
CHH | K013173 |
| Apr 3, 2017 | Beckman Coulter Inc. Cholesterol Reagent(CHOL 2 x 300), Catalog No. 467825
Intended for quantitative determination of cholesterol concentration in human serum or plasma. Terminated |
CHH | None listed |
| Dec 29, 2016 | Sterling 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 |
CHH | None listed |
| Apr 13, 2016 | Beckman 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 |
CHH | None listed |
| Mar 17, 2016 | Siemens Healthcare Diagnostics, Inc. Advia Chemistry Assays - Cholesterol_2 concentrated and Cholesterol, LDL Cholesterol Terminated |
CHH | K023504 |
| Feb 2, 2016 | Horiba 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 |
CHH | K060854 |
| Jun 27, 2015 | Roche 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 |
CHH | K031824 |
| Jun 27, 2015 | Roche 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 |
CHH | K952127 |
| Jan 28, 2015 | Beckman Coulter Inc. Beckman Coulter, Cholesterol Assay, Catalog No. OSR6X16 Terminated |
CHH | K925603 |
| Nov 15, 2013 | Ortho-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 |
CHH | K012593 K820263 |
| Feb 6, 2012 | Alere San Diego Alere Cholestech LDX Analyzer, Model Number: 10-004, 14-874, 14-875, in vitro diagnostic. Terminated |
CHH | K901900 |
| Dec 16, 2010 | Diagnostic 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 |
CHH | K842160 |
| Apr 2, 2010 | Polymer 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 |
CHH | K071593 |
| Mar 15, 2010 | Polymer 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 |
CHH | K022898 K023558 |
| Mar 1, 2010 | Polymer 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 |
CHH | K981493 K990688 |
| Dec 31, 2002 | Elan Diagnostics, Inc. Elan Diagnostics CHO ATAC Cholesterol Reagent Kit
Product Number: 516-250 Terminated |
CHH | K880237 |
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