LBR · Class I · 21 CFR 862.1475

FDA Product Code LBR: Ldl & Vldl Precipitation, Hdl

Leading manufacturers include Pointe Scientific, Inc.,, Ortho-Clinical Diagnostics, Inc. and Roche Diagnostic Systems, Inc..

66
Total
66
Cleared
71d
Avg days
1978
Since

FDA 510(k) Cleared Ldl & Vldl Precipitation, Hdl Devices (Product Code LBR)

66 devices
1–24 of 66
Cleared Jul 26, 2005
DIRECT HDL CHOLESTEROL AND DIRECT HDL/LDL CALIBRATOR
K050823
Teco Diagnostics
Chemistry · 117d
Cleared Dec 24, 2002
RAICHEM HDL CHOLESTEROL USING CANTROL HDL PRECIPITATING TUBES ON THE COBAS MIRA ANAYLZER
K023784
Hemagen Diagnostics, Inc.
Chemistry · 42d
Cleared Aug 30, 2001
VITROS CHEMISTRY PRODUCTS MAGNETIC HDL-CHOLESTEROL REAGENT, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 2
K012593
Ortho-Clinical Diagnostics, Inc.
Chemistry · 20d
Cleared Aug 05, 1999
AUTOHDL CHOLESTEROL REAGENT SET
K992002
Pointe Scientific, Inc.,
Chemistry · 51d
Cleared Jan 28, 1999
VITROS CHEMISTRY PRODUCTS MAGNETIC HDL-CHOLESTEROL REAGENT
K984303
Ortho-Clinical Diagnostics, Inc.
Chemistry · 57d
Cleared Apr 27, 1998
HDL-CHOLESTEROL PRECIPITATING REAGENT, CATALOGUE NUMBER 205-51
K980772
Diagnostic Chemicals , Ltd.
Chemistry · 66d
Cleared Apr 21, 1998
HDL UNI-PAKS (PTA), CATALOGUE NUMBER 215-51
K980770
Diagnostic Chemicals , Ltd.
Chemistry · 60d
Cleared Jan 26, 1998
BOEHRINGER MANNHEIM DIRECT LDL - CHOLESTEROL
K974733
Boehringer Mannheim Corp.
Chemistry · 39d
Cleared Nov 21, 1997
ROCHE UNIMATE HDL DIRECT REAGEN (WITH POL CLAIM)
K973369
Roche Diagnostic Systems, Inc.
Chemistry · 74d
Cleared Dec 10, 1993
HDL-CHOLESTRAL(DEXTRAN SULFATE/MAGNESIUM)
K932766
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 185d
Cleared Aug 16, 1993
HDL PRECIPITATING REAGENT (DEXTRAN SULFATE)
K931773
King Diagnostics, Inc.
Chemistry · 129d
Cleared Nov 09, 1992
SYNERMED HDL CHOLESTLEROL REAGENT KIT
K924427
Synermed, Inc.
Chemistry · 69d
Cleared Jan 09, 1992
IL TEST(TM) HDL CHOLESTEROL
K914811
Instrumentation Laboratory CO
Chemistry · 76d
Cleared Dec 11, 1990
HDL-CHOLESTEROL PRECIPITANT 7773/7573/7473/7173
K905284
Amresco, Inc.
Chemistry · 18d
Cleared Aug 09, 1990
REFLOTRON HDL CHOLESTEROL TEST TABS
K902568
Boehringer Mannheim Corp.
Chemistry · 59d
Cleared Jul 31, 1990
COULTER HDL - CHOLESTEROL REAGENT
K902174
Coulter Corp.
Chemistry · 78d
Cleared Mar 09, 1990
ROCHE SEPARATING REAGENT FOR HDL CHOLESTEROL
K900120
Roche Diagnostic Systems, Inc.
Chemistry · 59d
Cleared Apr 10, 1989
HDL CHOLESTEROL REAGENT
K891117
Pointe Scientific, Inc.,
Chemistry · 39d
Cleared Feb 17, 1989
HDL CHOLESTEROL REAGENT (PTA/MGCL2)
K890023
Sigma Diagnostics, Inc.
Chemistry · 44d
Cleared Feb 10, 1989
HDL CHOLESTEROL TEST
K885265
Em Diagnostic Systems, Inc.
Chemistry · 50d
Cleared Sep 13, 1988
IQ HDL CHOLESTEROL
K883353
Bd Becton Dickinson Vacutainer Systems Preanalytic
Chemistry · 35d
Cleared Jun 10, 1988
HDL CHOLESTEROL KIT
K881244
Trace Scientific , Ltd.
Chemistry · 79d
Cleared May 27, 1988
HDL CHOLESTEROL PRECIPITATING PROCEDURE
K881326
Data Medical Associates, Inc.
Chemistry · 59d
Cleared Feb 18, 1988
HDL CHOLESTEROL PRECIPITATING REAGENT
K880176
Tech-Co, Inc.
Chemistry · 34d

About Product Code LBR - Regulatory Context