Ldl & Vldl Precipitation, Hdl

FDA product code LBR · 65 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: 1978-05-19 – 2008-01-22

LBR 2008-01-22

DIAZYME LDL-CHOLESTEROL REAGENT, CALIBRATOR AND CONTROLS

Applicant General Atomics

K number K072523

View details →

LBR 2005-07-26

DIRECT HDL CHOLESTEROL AND DIRECT HDL/LDL CALIBRATOR

Applicant Teco Diagnostics

K number K050823

View details →

LBR 2002-12-24

RAICHEM HDL CHOLESTEROL USING CANTROL HDL PRECIPITATING TUBES ON THE COBAS MIRA ANAYLZER

Applicant Hemagen Diagnostics, Inc.

K number K023784

View details →

LBR 2001-08-30

VITROS CHEMISTRY PRODUCTS MAGNETIC HDL-CHOLESTEROL REAGENT, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 2

Applicant Ortho-Clinical Diagnostics, Inc.

K number K012593

View details →

LBR 1999-08-12

ATAC DIRECT HDL CHOLESTEROL REAGENT AND ATAC HDL-C CALIBRATOR KITS

Applicant Elan Diagnostics

K number K992029

View details →

LBR 1999-08-05

AUTOHDL CHOLESTEROL REAGENT SET

Applicant Pointe Scientific, Inc.,

K number K992002

View details →

LBR 1999-07-09

ATAC-PAK DIRECT HDL CHOLESTEROL REAGENT AND ATAC HDL-C CALIBRATOR KITS

Applicant Elan Holdings, Inc.

K number K991789

View details →

LBR 1999-05-28

MTM BIOSCANNER HDL, MODEL # BSA450, BSA460, BSA470

Applicant Polymer Technology Systems, Inc.

K number K990247

View details →

LBR 1999-01-28

VITROS CHEMISTRY PRODUCTS MAGNETIC HDL-CHOLESTEROL REAGENT

Applicant Ortho-Clinical Diagnostics, Inc.

K number K984303

View details →

LBR 1998-04-27

HDL-CHOLESTEROL PRECIPITATING REAGENT, CATALOGUE NUMBER 205-51

Applicant Diagnostic Chemicals , Ltd.

K number K980772

View details →

LBR 1998-04-21

HDL UNI-PAKS (PTA), CATALOGUE NUMBER 215-51

Applicant Diagnostic Chemicals , Ltd.

K number K980770

View details →

LBR 1998-01-26

BOEHRINGER MANNHEIM DIRECT LDL - CHOLESTEROL

Applicant Boehringer Mannheim Corp.

K number K974733

View details →

LBR 1997-11-21

ROCHE UNIMATE HDL DIRECT REAGEN (WITH POL CLAIM)

Applicant Roche Diagnostic Systems, Inc.

K number K973369

View details →

LBR 1997-06-18

N-GENEOUS LDL CHOLESTEROL REAGENT, N-GENEOUS LDL CHOLESTEROL CALIBRATOR, GENZYME LDL CHOLESTEROL CONTROL SET

Applicant Genzyme Corp.

K number K971573

View details →

LBR 1997-03-13

TRACE HDL CHOLESTEROL - AUTOMATED (HOMOGEN

Applicant Trace America, Inc.

K number K962723

View details →

LBR 1996-08-19

N-GENEOUS HDL CHOLESTEROL KIT/CHOLESTEROL CALIBRATOR

Applicant Genzyme Corp.

K number K962186

View details →

LBR 1995-12-11

HDL PRECIPITATING REAGENT

Applicant Schiapparelli Biosystems, Inc.

K number K954179

View details →

LBR 1995-08-02

MAGNETIC HDL CHOLESTEROL TEST

Applicant Reference Diagnostics, Inc.

K number K944975

View details →

LBR 1994-09-06

PBI PLUS HDL PRECIPITATING REAGENT

Applicant Merchant House Scientific

K number K941744

View details →

LBR 1993-12-10

HDL-CHOLESTRAL(DEXTRAN SULFATE/MAGNESIUM)

Applicant Diagnostic Chemicals, Ltd. (Usa)

K number K932766

View details →

LBR 1993-12-09

SPINPRO HDL PRECIPITATING REAGENT

Applicant Merchant House Scientific

K number K934961

View details →

LBR 1993-12-07

SPINPRO HDL PRECIPITATING REAGENT

Applicant Merchant House Scientific

K number K934801

View details →

LBR 1993-11-16

INTERSECT SYSTEMS HDL CHOLESTEROL REAGENT SET

Applicant Intersect Systems, Inc.

K number K934039

View details →

LBR 1993-08-16

HDL PRECIPITATING REAGENT (DEXTRAN SULFATE)

Applicant King Diagnostics, Inc.

K number K931773

View details →

LBR 1992-11-09

SYNERMED HDL CHOLESTLEROL REAGENT KIT

Applicant Synermed, Inc.

K number K924427

View details →

LBR 1992-01-09

IL TEST(TM) HDL CHOLESTEROL

Applicant Instrumentation Laboratory CO

K number K914811

View details →

LBR 1991-08-16

HIGH DENSITY LIPOPROTEIN CHOLESTEROL

Applicant Creative Laboratory Products, Inc.

K number K912823

View details →

LBR 1991-07-18

MAGNETIC HDL CHOLESTEROL TEST

Applicant Reference Diagnostics, Inc.

K number K911906

View details →

LBR 1991-05-22

HDL CHOLESTEROL REAGENT

Applicant Genzyme Corp.

K number K911406

View details →

LBR 1991-01-15

ICA PLASMA HDL AND LDL MEASUREMENT SYSTEM

Applicant Institute For Clinical Applications

K number K903733

View details →

LBR 1990-12-11

HDL-CHOLESTEROL PRECIPITANT 7773/7573/7473/7173

Applicant Amresco, Inc.

K number K905284

View details →

LBR 1990-11-28

BIOTROL HDL CHOLESTEROL PRECIPITATION REAGENT

Applicant Biotron U.S.A., Inc.

K number K904184

View details →

LBR 1990-08-29

STAT TEST HDL/CHOLESTEROL TEST KIT

Applicant Diagnostic Resources, Inc.

K number K903094

View details →

LBR 1990-08-09

REFLOTRON HDL CHOLESTEROL TEST TABS

Applicant Boehringer Mannheim Corp.

K number K902568

View details →

LBR 1990-07-31

COULTER HDL - CHOLESTEROL REAGENT

Applicant Coulter Corp.

K number K902174

View details →

LBR 1990-03-09

ROCHE SEPARATING REAGENT FOR HDL CHOLESTEROL

Applicant Roche Diagnostic Systems, Inc.

K number K900120

View details →

LBR 1989-11-08

HDL SINGLES

Applicant Trace America, Inc.

K number K895381

View details →

LBR 1989-07-25

HDL PRECIPITATING REAGENT

Applicant Diagnostic Systems

K number K893966

View details →

LBR 1989-04-10

HDL CHOLESTEROL REAGENT

Applicant Pointe Scientific, Inc.,

K number K891117

View details →

LBR 1989-03-08

STATSPIN HDL-CHOLESTEROL PRECIPITATING MICRO TUBE

Applicant Norfolk Scientific, Inc.

K number K890669

View details →

LBR 1989-02-17

HDL CHOLESTEROL REAGENT (PTA/MGCL2)

Applicant Sigma Diagnostics, Inc.

K number K890023

View details →

LBR 1989-02-10

HDL CHOLESTEROL TEST

Applicant Em Diagnostic Systems, Inc.

K number K885265

View details →

LBR 1988-09-13

IQ HDL CHOLESTEROL

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K number K883353

View details →

LBR 1988-08-15

CANTROL HDL CHOLESTEROL PRECIPI. REAG. AND TUBES

Applicant Canyon Diagnostics, Inc.

K number K882488

View details →

LBR 1988-06-10

HDL CHOLESTEROL KIT

Applicant Trace Scientific , Ltd.

K number K881244

View details →

LBR 1988-05-27

HDL CHOLESTEROL PRECIPITATING PROCEDURE

Applicant Data Medical Associates, Inc.

K number K881326

View details →

LBR 1988-02-18

HDL CHOLESTEROL PRECIPITATING REAGENT

Applicant Tech-Co, Inc.

K number K880176

View details →

LBR 1988-01-07

MULTICHEM HDL PRECIPITATING REAGENT #S0914

Applicant Simmler, Inc.

K number K874820

View details →

LBR 1986-06-27

WORTHINGTON HDL PRECIPITATING REAGENT SET

Applicant Cooper Biomedical, Inc.

K number K861926

View details →

LBR 1985-07-08

HDL CHOLESTEROL PRETREATMENT

Applicant American Monitor Corp.

K number K852350

View details →

LBR 1984-11-02

HDL PRECIPATATING REAGENT SET

Applicant Livonia Diagnostics, Inc.

K number K843894

View details →

LBR 1984-02-13

HDL CHOLESTEROL PRETREATMENT

Applicant American Monitor Corp.

K number K834251

View details →

LBR 1984-02-09

HDL EZ-TAB

Applicant Preventive Diagnostics Corp.

K number K833160

View details →

LBR 1984-01-13

HDL EX-SEP PRECIPITATING REAGENT

Applicant Preventive Diagnostics Corp.

K number K833431

View details →

LBR 1983-03-21

RAICHEM HDL-CHOLESTEROL REAGENT

Applicant Reagents Applications, Inc.

K number K830207

View details →

LBR 1982-07-13

HDL PRECIPITANT REAGENT SET

Applicant Omega Medical Electronics

K number K821203

View details →

LBR 1981-12-03

HDL CHOLESTEROL REAGENT SET

Applicant Anco Medical Reagents & Assoc.

K number K812839

View details →

LBR 1981-09-24

HDL CHOLESTEROL REAGENT

Applicant Pointe Scientific, Inc.,

K number K812574

View details →

LBR 1980-05-14

HDL REAGENT

Applicant Gilford Diagnostics

K number K800996

View details →

LBR 1979-12-07

CHOL-HDL TEST, HIGH LIPO. CHOL TEST

Applicant Sclavo, Inc.

K number K792313

View details →

LBR 1979-06-28

LANCER HDL SEPARATION KIT

Applicant Sherwood Medical Co.

K number K790865

View details →

LBR 1979-05-03

H-D-EL

Applicant General Diagnostics

K number K790372

View details →

LBR 1979-04-04

A-GENT-HDL REAGENT

Applicant Abbott Laboratories

K number K790329

View details →

LBR 1978-08-14

HDL CENTRIFIKIT

Applicant Beckman Instruments, Inc.

K number K781093

View details →

LBR 1978-05-19

ALFATEST

Applicant Panmed, Inc.

K number K780542

View details →