510(k) K241800

Device: Atellica® CH HDL Cholesterol (HDLC)& Atellica® CH LDL Cholesterol (LDLC)
Applicant: Siemens Healthcare Diagnostics, Inc.
510(k) number: K241800
Product code: MRR
Decision: Substantially Equivalent (SESE)
Decision date: 2024-07-26
Date received: 2024-06-21
Regulation: 862.1475
Classification name: System, Test, Low Density, Lipoprotein
Medical specialty: Clinical Chemistry
Review panel: Clinical Chemistry
Device class: 1
Clearance type: Traditional
Statement or summary: Summary
Third party reviewed: No

Applicant Contact#

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K210801	AXINON® LDL-p Test System	Numares AG	2023-07-19
K161691	Direct LDL Cholesterol (LDL)	Randox Laboratories Limited	2017-03-20
K091333	S-TEST LDL CHOLESTEROL (LDL), MODEL RC0022	Alfa Wassermann, Inc.	2009-08-03
K090734	EASYRA DLDL REAGENT, CALIBRATOR; EASYQC CHEMISTRY NO ELECTROLYTES, WITH ELECTROLYTES	Medica Corp.	2009-07-17
K063841	NMR PROFILER AND NMR LIPOPROFILE ASSAY, CONTROLS	Liposcience	2008-07-23
K051121	DIRECT LDL CHOLESTEROL, MODEL L530-60H	Teco Diagnostics	2005-08-08
K043264	LDL-EX SEIKEN ASSAY KIT	Denka Seiken Co., Ltd.	2005-01-26
K041927	LDL/ADVANCE ASSAY, CAT. NO. 279-20, 279-40	Diagnostic Chemicals , Ltd.	2004-11-23
K041720	VITROS CHEMISTRY PRODUCTS DLDL REAGENT, CALIBRATOR KIT 19, FS CALIBRATOR 1 AND PERFORMANCE VERIFIERS I AND II	Ortho-Clinical Diagnostics, Inc.	2004-08-25
K040693	PTS PANELS LDL CHOLESTEROL TEST STRIPS	Polymer Technology Systems, Inc.	2004-07-06
K022772	RAICHEM LDL-CHOLESTEROL DIRECT REAGENT	Hemagen Diagnostics, Inc.	2002-09-17
K020724	DIMENSION AUTOMATED LDL CHOLESTEROL FLEX REAGENTCARTRIDGE METHOD, MODEL DF131	Dade Behring, Inc.	2002-05-09
K020575	ATAC DIRECT LDL REAGENT AND ATAC DIRECT LDL CALIBRATOR KITS	Elan Diagnostics	2002-04-12
K014103	SYNCHRON SYSTEMS DIRECT LDL CHLOESTEROL REAGENT AND CALIBRATOR	Beckman Coulter, Inc.	2002-01-28
K012287	MODIFICATION TO: COBAS INTEGRA LDL-CHOLESTEROL PLUS 2ND GENERATION	Roche Diagnostics Corp.	2001-08-07