510(k) K053157

Device: AUTOMATED HDL CHOLESTEROL FLEX REAGENT CARTRIDGE, MODEL DF48A
Applicant: Dade Behring, Inc.
510(k) number: K053157
Product code: LBS
Decision: Substantially Equivalent (SESE)
Decision date: 2005-12-09
Date received: 2005-11-14
Regulation: 862.1475
Classification name: Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl
Medical specialty: Clinical Chemistry
Review panel: Clinical Chemistry
Device class: 1
Clearance type: Special
Statement or summary: Summary
Third party reviewed: N

Applicant Contact#

Contact: VICTOR M CARRIO
Address: P.O. Box 6101 Bldg. 500 Glasgow Business Community Newark, DE US 19714 19714

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K162593	HDL-Cholesterol Gen.4	Roche Diagnostics Operations (Rdo)	2016-10-19
K153435	Direct HDL Cholesterol (HDL)	Randox Laboratories, Ltd.	2016-01-08
K132711	CAROLINA LIQUID CHEMISTRIES HDL CHOLESTEROL REAGENT	Carolina Liquid Chemistries Corp.	2014-05-08
K120609	VITROS CHEMISTRY PRODUCTS DHDL SLIDES	Ortho-Clinical Diagnostics, Inc.	2012-09-07
K111516	NMR LIPOPROFILE (R) TEST AND NMR PROFILER	Liposcience, Inc.	2011-09-27
K103747	ELITECH CLINCAL SYSTEMS CHOLESTEROL HDL SL 2G, HDL 2G CALIBRATOR, LDL SL 2G, LDL 2G CALIBRATOR, ELITROL II & ELITECH SYS	Elitechgroup Seppim S.A.S.	2011-08-31
K111036	EASYRA HDL REAGENT; EASYRA LDL REAGENT; EASYRA CHOL REAGENT; EASYRA TRIG REAGENT	Medica Corporation	2011-07-12
K100550	POLY-CHEM 90 DIRECT HDL CHOLESTEROL, POLY-CHEM 90 DIRECT LDL CHOLESTEROL, POLY-CHEM 90 CHOLESTEROL, POLY-CHEM 90 TRIGLYC	Polymedco, Inc.	2010-09-28
K100010	HDL CHOLESTEROL (HDLX) ASSAY	Beckman Coulter, Inc.	2010-05-14
K080125	APOLOWAKO T-CHO, HDL-C, TG AND ANALYZER, MODELS 993-23501, 999-23601, 995-23701 AND 993-25201	Wako Chemicals USA, Inc.	2008-07-18
K073497	HDL CHOLESTEROL REAGENT, MODEL 10211	Medica Corp.	2008-04-14
K072395	DIAZYME HDL-CHOLESTEROL REAGENT,CALIBRATOR, CONTROLS	Diazyme Laboratories	2008-01-03
K072836	CHOLESTRAK HDL CHOLESTEROL HOME TEST	Accutech, LLC	2007-12-27
K071706	ENVOY 500 HDL; CHOLESTEROL REAGENT KIT (MODEL# 55301), CALIBRATOR KIT (MODEL# 55118)	Clinical Data, Inc.	2007-12-20
K062092	PREVU POINT OF CARE SKIN STEROL TEST	Premd, Inc.	2006-09-15