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

FDA product code LBS · 79 cleared devices

Class 1 Clinical Chemistry

Regulation: 21 CFR 862.1475
Review panel: CH
Implant: No
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1979-03-21 – 2016-10-19

LBS 2016-10-19

HDL-Cholesterol Gen.4

Applicant Roche Diagnostics Operations (Rdo)

K number K162593

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LBS 2016-01-08

Direct HDL Cholesterol (HDL)

Applicant Randox Laboratories, Ltd.

K number K153435

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LBS 2012-09-07

VITROS CHEMISTRY PRODUCTS DHDL SLIDES

Applicant Ortho-Clinical Diagnostics, Inc.

K number K120609

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LBS 2011-09-27

NMR LIPOPROFILE (R) TEST AND NMR PROFILER

Applicant Liposcience, Inc.

K number K111516

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LBS 2011-08-31

ELITECH CLINCAL SYSTEMS CHOLESTEROL HDL SL 2G, HDL 2G CALIBRATOR, LDL SL 2G, LDL 2G CALIBRATOR, ELITROL II & ELITECH SYS

Applicant Elitechgroup Seppim S.A.S.

K number K103747

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LBS 2011-07-12

EASYRA HDL REAGENT; EASYRA LDL REAGENT; EASYRA CHOL REAGENT; EASYRA TRIG REAGENT

Applicant Medica Corporation

K number K111036

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LBS 2010-09-28

POLY-CHEM 90 DIRECT HDL CHOLESTEROL, POLY-CHEM 90 DIRECT LDL CHOLESTEROL, POLY-CHEM 90 CHOLESTEROL, POLY-CHEM 90 TRIGLYC

Applicant Polymedco, Inc.

K number K100550

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LBS 2010-05-14

HDL CHOLESTEROL (HDLX) ASSAY

Applicant Beckman Coulter, Inc.

K number K100010

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LBS 2008-07-18

APOLOWAKO T-CHO, HDL-C, TG AND ANALYZER, MODELS 993-23501, 999-23601, 995-23701 AND 993-25201

Applicant Wako Chemicals USA, Inc.

K number K080125

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LBS 2008-04-14

HDL CHOLESTEROL REAGENT, MODEL 10211

Applicant Medica Corp.

K number K073497

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LBS 2008-01-03

DIAZYME HDL-CHOLESTEROL REAGENT,CALIBRATOR, CONTROLS

Applicant Diazyme Laboratories

K number K072395

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LBS 2007-12-27

CHOLESTRAK HDL CHOLESTEROL HOME TEST

Applicant Accutech, LLC

K number K072836

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LBS 2007-12-20

ENVOY 500 HDL; CHOLESTEROL REAGENT KIT (MODEL# 55301), CALIBRATOR KIT (MODEL# 55118)

Applicant Clinical Data, Inc.

K number K071706

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LBS 2006-09-15

PREVU POINT OF CARE SKIN STEROL TEST

Applicant Premd, Inc.

K number K062092

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LBS 2005-12-09

AUTOMATED HDL CHOLESTEROL FLEX REAGENT CARTRIDGE, MODEL DF48A

Applicant Dade Behring, Inc.

K number K053157

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LBS 2005-08-25

ULTRA HDL

Applicant Abbott Laboratories

K number K051962

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LBS 2005-05-26

ADVIA IMS DIRECT HDL CHOLESTEROL ASSAY

Applicant Bayer Healthcare, LLC

K number K050632

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LBS 2004-11-23

HDL-ADVANCE ASSAY, CAT. NO. 278-20, 278-50A, 278-50B

Applicant Diagnostic Chemicals , Ltd.

K number K041928

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LBS 2004-10-29

HDL-EX SEIKEN ASSAY KIT

Applicant Denka Seiken Co., Ltd.

K number K041090

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LBS 2004-10-28

VITROS CHEMISTRY PRODUCTS DHDL SLIDES, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 25, VITROS CHEMISTRY PRODUCTS PERFORMACE

Applicant Ortho-Clinical Diagnostics, Inc.

K number K042006

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LBS 2004-09-16

SYNCHRON SYSTEMS HDL CHOLESTEROL (HDL), SYNCHRON SYSTEMS LIPID PLUS CALIBRATORS 1 & 2, MODELS A15625/A16747

Applicant Beckman Coulter, Inc.

K number K042195

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LBS 2004-06-07

SYNCHRON SYSTEMS HDL CHOLESTEROL (HDLD) REAGENT

Applicant Beckman Coulter, Inc.

K number K040767

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LBS 2004-03-10

DIRECT HDL-CHOLESTEROL LIQUID COLOR; DIRECT HDL/LDL-CHOLESTEROL CALIBRATOR

Applicant Stanbio Laboratory

K number K032932

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LBS 2003-12-05

HDL-CHOLESTEROL PLUS 2ND GENERATION

Applicant Roche Diagnostics Corp.

K number K033610

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LBS 2003-01-24

PICCOLO HDL TEST SYSTEM

Applicant Abaxis, Inc.

K number K023640

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LBS 2002-07-25

ULTRA N-GENEOUS HDL CHOLESTEROL REAGENT 1/REAGENT2; ULTRA N-GENEOUS HDL CHOLESTREOL CALIBRATOR

Applicant Genzyme Corp.

K number K021316

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LBS 2002-07-19

JAS HDL CHOLESTEROL (AUTOMATED) REAGENT

Applicant Jas Diagnostics, Inc.

K number K021671

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LBS 2002-06-24

CHOLESTEROL 1, 2, 3

Applicant Imi

K number K014018

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LBS 2002-02-08

OLYMPUS LDL CHOLESTEROL REAGENT, OLYMPUS LDL CHOLESTEROL CALIBRATOR, OLYMPUS HDL/LDL CHOLESTEROL CONTROL SERA

Applicant Olympus America, Inc.

K number K014032

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LBS 2002-02-08

OLYMPUS HDL CHOLESTEROL REAGENT; OLYMPUS HDL CHOLESTEROL CALIBRATOR; OLYMPUS HDL/LDL CHOLESTEROL CONTROL SERA

Applicant Olympus America, Inc.

K number K014015

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LBS 2001-11-09

ATAC PAK DIRECT HDL REAGENT AND ATAC DIRECT HDL CALIBRATOR KITS

Applicant Elan Holdings, Inc.

K number K013152

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LBS 2001-08-08

MODIFICATION TO:COBAS INTEGRA HDL-CHOLESTEROL PLUS 2ND GENERATION

Applicant Roche Diagnostics Corp.

K number K012286

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LBS 1999-08-19

LDL CHOLESTEROL, PRODUCT NO'S, 124-01, CH102-01

Applicant A.P. Total Care, Inc.

K number K991664

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LBS 1999-08-10

HDL CHOLESTEROL, PRODUCT NO'S 124-01, CH102-01

Applicant A.P. Total Care, Inc.

K number K991665

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LBS 1999-06-18

DIRECT HDL-CHOLESTEROL REAGENT

Applicant Kamiya Biomedical Co.

K number K990581

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LBS 1998-09-15

HDLC PRECIPITATING REAGENT

Applicant Ac Biochemicals, Inc.

K number K982539

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LBS 1998-08-03

DIRECT HDL

Applicant Abbott Laboratories

K number K981224

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LBS 1998-07-30

DIRECT HDL-CHOLESTROL LIQUID

Applicant Randox Laboratories, Ltd.

K number K982341

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LBS 1998-07-14

CARESIDE HDL-CHOLESTEROL

Applicant Exigent Diagnostics, Inc.

K number K981899

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LBS 1998-06-11

HDL

Applicant Abbott Laboratories

K number K981580

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LBS 1997-12-22

RDI HOMOGENEOUS HDL CHOLESTEROL TEST

Applicant Reference Diagnostics, Inc.

K number K973988

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LBS 1997-07-22

EZ HDL CHOLESTEROL REAGENT(PROCEDURE 354)/EZ HDL CALIBRATOR (354-5)

Applicant Sigma Diagnostics, Inc.

K number K972041

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LBS 1997-06-16

ROCHE UNIMATE HDL DIRECT REAGENT, ROCHE CALIBRATOR HDL DIRECT

Applicant Roche Diagnostic Systems, Inc.

K number K971902

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LBS 1997-06-16

N-GENEOUS HDL CHOLESTEROL KIT/CHOLESTEROL CALIBRATOR

Applicant Genzyme Corp.

K number K971190

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LBS 1997-06-16

LIQUID N-GENEOUS HDL CHOLESTEROL KIT/CALIBRATOR

Applicant Genzyme Corp.

K number K971162

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LBS 1997-06-06

BOEHRINGER MANNHEIM DIRECT HDL-CHOLESTEROL

Applicant Randox Laboratories, Ltd.

K number K970735

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LBS 1997-05-21

ACE HDL-C REAGENT

Applicant Schiapparelli Biosystems, Inc.

K number K971526

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LBS 1996-10-23

BOEHRINGER MANNHEIM DIRECT HDL-CHOLESTEROL

Applicant Boehringer Mannheim Corp.

K number K963213

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LBS 1995-11-24

CHOLESTECH LDX SYSTEM

Applicant Cholestech Corp.

K number K954778

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LBS 1995-05-01

ACCUMETER HDL CHOLESTEROL TEST

Applicant Chemtrak, Inc.

K number K943279

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LBS 1994-12-07

HDL QVET

Applicant Prisma Systems

K number K943028

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LBS 1993-10-14

BECKMAN HDL CHOLESTEROL REAGENT

Applicant Beckman Instruments, Inc.

K number K934045

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LBS 1991-11-27

TECHNICON AXON(TM) SYSTEM METHODS ANYALYE HDL CHOL

Applicant Technicon Instruments Corp.

K number K914511

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LBS 1990-12-26

CHOLESTECH LIPID MONITORING SYSTEM,HDL CHOLESTEROL

Applicant Cholestech Corp.

K number K905296

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LBS 1990-03-09

IMMUNOTECH HDL-CHOLESTEROL TEST

Applicant Immunotech Corp.

K number K900036

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LBS 1989-12-27

CLINISTAT HDL CHOLESTEROL REAGENT TEST

Applicant Heraeus Kulzer, Inc.

K number K895139

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LBS 1989-11-29

SYNCHRON CX(R) SYSTEMS HDL CHOLESTEROL REAGENT

Applicant Beckman Instruments, Inc.

K number K895851

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LBS 1989-08-31

QUIKREAD WHOLE BLOOD HDL-CHOLESTEROL TEST KIT

Applicant Photec Diagnostics, Inc.

K number K894057

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LBS 1989-08-03

SERALYZER HDL CHOLESTEROL PROCEDURE USE W/STRIP

Applicant Heraeus Kulzer, Inc.

K number K893548

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LBS 1988-06-10

IQ HDL CHOLESTEROL

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K number K881891

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LBS 1987-11-24

EASY-TEST HDL CHOLESTEROL ITEM NUMBER 16683

Applicant Em Diagnostic Systems, Inc.

K number K874397

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LBS 1987-08-13

ANALYST(TM) LIPID ROTOR & HDL CALIBRATOR/CONTROL

Applicant E.I. Dupont DE Nemours & Co., Inc.

K number K871265

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LBS 1987-07-07

PARAMAX CHOLESTEROL REAGENT

Applicant American Dade

K number K872050

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LBS 1987-05-14

VISION (TM) HDL CHOLESTEROL

Applicant Abbott Laboratories

K number K871461

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LBS 1987-02-04

ASTRA SYSTEMS MULTIPLE CHEMISTRY MODULE

Applicant Beckman Instruments, Inc.

K number K864522

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LBS 1986-09-29

HDL/CHOLESTEROL TEST SYSTEM

Applicant Chrometrics Laboratories, Inc.

K number K861244

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LBS 1986-08-29

EMDS (TM) HDL CHOLESTEROL ITEM NO. 67679/95

Applicant Em Diagnostic Systems, Inc.

K number K862845

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LBS 1984-08-27

HIGH DENSITY LIPOPROTEIN PRECIPITATIN

Applicant Diagnostic Chemicals, Ltd. (Usa)

K number K843029

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LBS 1984-04-13

HDL EZ-TZ3 CHOLESTEROL REAGENT KIT

Applicant Preventive Diagnostics Corp.

K number K840677

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LBS 1984-04-04

PDC HDL EZ-SEP CHOLESTEROL REAGENT

Applicant Preventive Diagnostics Corp.

K number K840676

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LBS 1981-11-27

HDL-C EIKEN

Applicant Syn-Kit, Inc.

K number K813192

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LBS 1980-09-16

WAKO HDL CHOLESTEROL TEST

Applicant Wako Pure Chemical Industries, Ltd.

K number K801834

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LBS 1980-09-09

HDL CHOLESTEROL TEST KIT

Applicant Mallinckrodt Critical Care

K number K801726

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LBS 1980-06-17

CENTRIFICHEM HDL CHOLESTEROL

Applicant Union Carbide Corp.

K number K801133

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LBS 1979-12-06

COULTER HDL CHOLESTEROL REAG. SYSTEM

Applicant Coulter Electronics, Inc.

K number K792319

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LBS 1979-11-13

DADE HIGH DENSITY LIPOPROTEIN CHOLESTERO

Applicant Dade, Baxter Travenol Diagnostics, Inc.

K number K792183

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LBS 1979-10-17

TECHNICON HDL CHOLESTEROL METHOD

Applicant Technicon Instruments Corp.

K number K791990

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LBS 1979-06-15

CHOLESTEROL KIT, HDL-DS

Applicant Beckman Instruments, Inc.

K number K790553

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LBS 1979-03-21

DIAGNOSTIC SET, LIPO-FRAX

Applicant Analytical Products, Inc.

K number K790281

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