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

Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl

Regulation 862.1475

0510(k)s in 12 months (80 all time)
1recalls in 12 months (9 all time)
8recalls that name a 510(k)
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Top companies in LBS

Company510(k)sRecalls
Abbott Laboratories40
Beckman Coulter, Inc.31
Beckman Instruments, Inc.40
Ortho-Clinical Diagnostics, Inc.22
Genzyme Corp.30
Randox Laboratories, Ltd.30
Roche Diagnostics Corp.21
A.P. Total Care, Inc.20
Cholestech Corp.20
Diagnostic Chemicals , Ltd.20
Decided510(k)Device and applicantCode
Oct 19, 2016K162593HDL-Cholesterol Gen.4
Roche Diagnostics Operations (Rdo)
LBS
Jan 8, 2016K153435Direct HDL Cholesterol (HDL)
Randox Laboratories, Ltd., GB
LBS
May 8, 2014K132711CAROLINA LIQUID CHEMISTRIES HDL CHOLESTEROL REAGENT
Carolina Liquid Chemistries Corp.
LBS
Sep 7, 2012K120609VITROS CHEMISTRY PRODUCTS DHDL SLIDES
Ortho-Clinical Diagnostics, Inc.
LBS
Sep 27, 2011K111516NMR LIPOPROFILE (R) TEST AND NMR PROFILER
Liposcience, Inc.
LBS
Aug 31, 2011K103747ELITECH CLINCAL SYSTEMS CHOLESTEROL HDL SL 2G, HDL 2G CALIBRATOR, LDL SL 2G, LDL 2G CALIBRATOR, ELITROL II & ELITECH SYS
Elitechgroup Seppim S.A.S.
LBS
Jul 12, 2011K111036EASYRA HDL REAGENT; EASYRA LDL REAGENT; EASYRA CHOL REAGENT; EASYRA TRIG REAGENT
Medica Corporation
LBS
Sep 28, 2010K100550POLY-CHEM 90 DIRECT HDL CHOLESTEROL, POLY-CHEM 90 DIRECT LDL CHOLESTEROL, POLY-CHEM 90 CHOLESTEROL, POLY-CHEM 90 TRIGLYC
Polymedco, Inc.
LBS
May 14, 2010K100010HDL CHOLESTEROL (HDLX) ASSAY
Beckman Coulter, Inc.
LBS
Jul 18, 2008K080125APOLOWAKO T-CHO, HDL-C, TG AND ANALYZER, MODELS 993-23501, 999-23601, 995-23701 AND 993-25201
Wako Chemicals USA, Inc.
LBS
Apr 14, 2008K073497HDL CHOLESTEROL REAGENT, MODEL 10211
Medica Corp.
LBS
Jan 3, 2008K072395DIAZYME HDL-CHOLESTEROL REAGENT,CALIBRATOR, CONTROLS
Diazyme Laboratories
LBS
Dec 27, 2007K072836CHOLESTRAK HDL CHOLESTEROL HOME TEST
Accutech, LLC
LBS
Dec 20, 2007K071706ENVOY 500 HDL; CHOLESTEROL REAGENT KIT (MODEL# 55301), CALIBRATOR KIT (MODEL# 55118)
Clinical Data, Inc.
LBS
Sep 15, 2006K062092PREVU POINT OF CARE SKIN STEROL TEST
Premd, Inc.
LBS
Dec 9, 2005K053157AUTOMATED HDL CHOLESTEROL FLEX REAGENT CARTRIDGE, MODEL DF48A
Dade Behring, Inc.
LBS
Aug 25, 2005K051962ULTRA HDL
Abbott Laboratories
LBS
May 26, 2005K050632ADVIA IMS DIRECT HDL CHOLESTEROL ASSAY
Bayer Healthcare, LLC
LBS
Nov 23, 2004K041928HDL-ADVANCE ASSAY, CAT. NO. 278-20, 278-50A, 278-50B
Diagnostic Chemicals , Ltd., CA
LBS
Oct 29, 2004K041090HDL-EX SEIKEN ASSAY KIT
Denka Seiken Co., Ltd., JP
LBS
Oct 28, 2004K042006VITROS CHEMISTRY PRODUCTS DHDL SLIDES, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 25, VITROS CHEMISTRY PRODUCTS PERFORMACE
Ortho-Clinical Diagnostics, Inc.
LBS
Sep 16, 2004K042195SYNCHRON SYSTEMS HDL CHOLESTEROL (HDL), SYNCHRON SYSTEMS LIPID PLUS CALIBRATORS 1 & 2, MODELS A15625/A16747
Beckman Coulter, Inc.
LBS
Jun 7, 2004K040767SYNCHRON SYSTEMS HDL CHOLESTEROL (HDLD) REAGENT
Beckman Coulter, Inc.
LBS
Mar 10, 2004K032932DIRECT HDL-CHOLESTEROL LIQUID COLOR; DIRECT HDL/LDL-CHOLESTEROL CALIBRATOR
Stanbio Laboratory
LBS
Dec 5, 2003K033610HDL-CHOLESTEROL PLUS 2ND GENERATION
Roche Diagnostics Corp.
LBS
Jan 24, 2003K023640PICCOLO HDL TEST SYSTEM
Abaxis, Inc.
LBS
Jul 25, 2002K021316ULTRA N-GENEOUS HDL CHOLESTEROL REAGENT 1/REAGENT2; ULTRA N-GENEOUS HDL CHOLESTREOL CALIBRATOR
Genzyme Corp.
LBS
Jul 19, 2002K021671JAS HDL CHOLESTEROL (AUTOMATED) REAGENT
Jas Diagnostics, Inc.
LBS
Jun 24, 2002K014018CHOLESTEROL 1, 2, 3
Imi
LBS
Feb 8, 2002K014032OLYMPUS LDL CHOLESTEROL REAGENT, OLYMPUS LDL CHOLESTEROL CALIBRATOR, OLYMPUS HDL/LDL CHOLESTEROL CONTROL SERA
Olympus America, Inc.
LBS
Feb 8, 2002K014015OLYMPUS HDL CHOLESTEROL REAGENT; OLYMPUS HDL CHOLESTEROL CALIBRATOR; OLYMPUS HDL/LDL CHOLESTEROL CONTROL SERA
Olympus America, Inc.
LBS
Nov 9, 2001K013152ATAC PAK DIRECT HDL REAGENT AND ATAC DIRECT HDL CALIBRATOR KITS
Elan Holdings, Inc.
LBS
Aug 8, 2001K012286MODIFICATION TO:COBAS INTEGRA HDL-CHOLESTEROL PLUS 2ND GENERATION
Roche Diagnostics Corp.
LBS
Aug 19, 1999K991664LDL CHOLESTEROL, PRODUCT NO'S, 124-01, CH102-01
A.P. Total Care, Inc.
LBS
Aug 10, 1999K991665HDL CHOLESTEROL, PRODUCT NO'S 124-01, CH102-01
A.P. Total Care, Inc.
LBS
Jun 18, 1999K990581DIRECT HDL-CHOLESTEROL REAGENT
Kamiya Biomedical Co.
LBS
Sep 15, 1998K982539HDLC PRECIPITATING REAGENT
Ac Biochemicals, Inc.
LBS
Aug 3, 1998K981224DIRECT HDL
Abbott Laboratories
LBS
Jul 30, 1998K982341DIRECT HDL-CHOLESTROL LIQUID
Randox Laboratories, Ltd., GB
LBS
Jul 14, 1998K981899CARESIDE HDL-CHOLESTEROL
Exigent Diagnostics, Inc.
LBS
Jun 11, 1998K981580HDL
Abbott Laboratories
LBS
Dec 22, 1997K973988RDI HOMOGENEOUS HDL CHOLESTEROL TEST
Reference Diagnostics, Inc.
LBS
Jul 22, 1997K972041EZ HDL CHOLESTEROL REAGENT(PROCEDURE 354)/EZ HDL CALIBRATOR (354-5)
Sigma Diagnostics, Inc.
LBS
Jun 16, 1997K971902ROCHE UNIMATE HDL DIRECT REAGENT, ROCHE CALIBRATOR HDL DIRECT
Roche Diagnostic Systems, Inc.
LBS
Jun 16, 1997K971190N-GENEOUS HDL CHOLESTEROL KIT/CHOLESTEROL CALIBRATOR
Genzyme Corp.
LBS
Jun 16, 1997K971162LIQUID N-GENEOUS HDL CHOLESTEROL KIT/CALIBRATOR
Genzyme Corp.
LBS
Jun 6, 1997K970735BOEHRINGER MANNHEIM DIRECT HDL-CHOLESTEROL
Randox Laboratories, Ltd., IE
LBS
May 21, 1997K971526ACE HDL-C REAGENT
Schiapparelli Biosystems, Inc.
LBS
Oct 23, 1996K963213BOEHRINGER MANNHEIM DIRECT HDL-CHOLESTEROL
Boehringer Mannheim Corp.
LBS
Nov 24, 1995K954778CHOLESTECH LDX SYSTEM
Cholestech Corp.
LBS

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