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510(k) K970735

Device
BOEHRINGER MANNHEIM DIRECT HDL-CHOLESTEROL
Applicant
RANDOX LABORATORIES, LTD.
510(k) number
K970735
Product code
LBS  
Decision
Substantially Equivalent (SESE)
Decision date
1997-06-06
Date received
1997-02-18
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
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
P. ARMSTONG
Address
Ardmore, Diamond Rd. Crumlin IE BT29 4QY BT29 4QY

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code LBS  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K162593HDL-Cholesterol Gen.4Roche Diagnostics Operations (Rdo)2016-10-19
K153435Direct HDL Cholesterol (HDL)Randox Laboratories, Ltd.2016-01-08
K132711CAROLINA LIQUID CHEMISTRIES HDL CHOLESTEROL REAGENTCarolina Liquid Chemistries Corp.2014-05-08
K120609VITROS CHEMISTRY PRODUCTS DHDL SLIDESOrtho-Clinical Diagnostics, Inc.2012-09-07
K111516NMR LIPOPROFILE (R) TEST AND NMR PROFILERLiposcience, Inc.2011-09-27
K103747ELITECH CLINCAL SYSTEMS CHOLESTEROL HDL SL 2G, HDL 2G CALIBRATOR, LDL SL 2G, LDL 2G CALIBRATOR, ELITROL II & ELITECH SYSElitechgroup Seppim S.A.S.2011-08-31
K111036EASYRA HDL REAGENT; EASYRA LDL REAGENT; EASYRA CHOL REAGENT; EASYRA TRIG REAGENTMedica Corporation2011-07-12
K100550POLY-CHEM 90 DIRECT HDL CHOLESTEROL, POLY-CHEM 90 DIRECT LDL CHOLESTEROL, POLY-CHEM 90 CHOLESTEROL, POLY-CHEM 90 TRIGLYCPolymedco, Inc.2010-09-28
K100010HDL CHOLESTEROL (HDLX) ASSAYBeckman Coulter, Inc.2010-05-14
K080125APOLOWAKO T-CHO, HDL-C, TG AND ANALYZER, MODELS 993-23501, 999-23601, 995-23701 AND 993-25201Wako Chemicals USA, Inc.2008-07-18
K073497HDL CHOLESTEROL REAGENT, MODEL 10211Medica Corp.2008-04-14
K072395DIAZYME HDL-CHOLESTEROL REAGENT,CALIBRATOR, CONTROLSDiazyme Laboratories2008-01-03
K072836CHOLESTRAK HDL CHOLESTEROL HOME TESTAccutech, LLC2007-12-27
K071706ENVOY 500 HDL; CHOLESTEROL REAGENT KIT (MODEL# 55301), CALIBRATOR KIT (MODEL# 55118)Clinical Data, Inc.2007-12-20
K062092PREVU POINT OF CARE SKIN STEROL TESTPremd, Inc.2006-09-15

Legacy Summary#

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FDA Review#

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