FDA Product Code LBR: Ldl & Vldl Precipitation, Hdl
Leading manufacturers include Pointe Scientific, Inc.,, Genzyme Corp. and Trace America, Inc..
66
Total
66
Cleared
71d
Avg days
1978
Since
FDA 510(k) Cleared Ldl & Vldl Precipitation, Hdl Devices (Product Code LBR)
66 devices
Cleared
Jan 28, 2015
LDLC3 LDL-Cholesterol Gen.3
Roche Diagnostics Operations (Rdo)
Chemistry
35d
Cleared
Jul 26, 2005
DIRECT HDL CHOLESTEROL AND DIRECT HDL/LDL CALIBRATOR
Teco Diagnostics
Chemistry
117d
Cleared
Dec 24, 2002
RAICHEM HDL CHOLESTEROL USING CANTROL HDL PRECIPITATING TUBES ON THE COBAS MIRA ANAYLZER
Hemagen Diagnostics, Inc.
Chemistry
42d
Cleared
Aug 30, 2001
VITROS CHEMISTRY PRODUCTS MAGNETIC HDL-CHOLESTEROL REAGENT, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 2
Ortho-Clinical Diagnostics, Inc.
Chemistry
20d
Cleared
Aug 12, 1999
ATAC DIRECT HDL CHOLESTEROL REAGENT AND ATAC HDL-C CALIBRATOR KITS
Elan Diagnostics
Chemistry
57d
Cleared
Aug 05, 1999
AUTOHDL CHOLESTEROL REAGENT SET
Pointe Scientific, Inc.,
Chemistry
51d
Cleared
Jul 09, 1999
ATAC-PAK DIRECT HDL CHOLESTEROL REAGENT AND ATAC HDL-C CALIBRATOR KITS
Elan Holdings, Inc.
Chemistry
45d
Cleared
May 28, 1999
MTM BIOSCANNER HDL, MODEL # BSA450, BSA460, BSA470
Polymer Technology Systems, Inc.
Chemistry
122d
Cleared
Jan 28, 1999
VITROS CHEMISTRY PRODUCTS MAGNETIC HDL-CHOLESTEROL REAGENT
Ortho-Clinical Diagnostics, Inc.
Chemistry
57d
Cleared
Apr 27, 1998
HDL-CHOLESTEROL PRECIPITATING REAGENT, CATALOGUE NUMBER 205-51
Diagnostic Chemicals , Ltd.
Chemistry
66d
Cleared
Apr 21, 1998
HDL UNI-PAKS (PTA), CATALOGUE NUMBER 215-51
Diagnostic Chemicals , Ltd.
Chemistry
60d
Cleared
Jan 26, 1998
BOEHRINGER MANNHEIM DIRECT LDL - CHOLESTEROL
Boehringer Mannheim Corp.
Chemistry
39d
Cleared
Nov 21, 1997
ROCHE UNIMATE HDL DIRECT REAGEN (WITH POL CLAIM)
Roche Diagnostic Systems, Inc.
Chemistry
74d
Cleared
Jun 18, 1997
N-GENEOUS LDL CHOLESTEROL REAGENT, N-GENEOUS LDL CHOLESTEROL CALIBRATOR, GENZYME LDL CHOLESTEROL CONTROL SET
Genzyme Corp.
Chemistry
49d
Cleared
Mar 13, 1997
TRACE HDL CHOLESTEROL - AUTOMATED (HOMOGEN
Trace America, Inc.
Chemistry
241d
Cleared
Aug 19, 1996
N-GENEOUS HDL CHOLESTEROL KIT/CHOLESTEROL CALIBRATOR
Genzyme Corp.
Chemistry
74d
Cleared
Dec 11, 1995
HDL PRECIPITATING REAGENT
Schiapparelli Biosystems, Inc.
Chemistry
96d
Cleared
Aug 02, 1995
MAGNETIC HDL CHOLESTEROL TEST
Reference Diagnostics, Inc.
Chemistry
295d
Cleared
Dec 10, 1993
HDL-CHOLESTRAL(DEXTRAN SULFATE/MAGNESIUM)
Diagnostic Chemicals, Ltd. (Usa)
Chemistry
185d
Cleared
Nov 16, 1993
INTERSECT SYSTEMS HDL CHOLESTEROL REAGENT SET
Intersect Systems, Inc.
Chemistry
90d
Cleared
Aug 16, 1993
HDL PRECIPITATING REAGENT (DEXTRAN SULFATE)
King Diagnostics, Inc.
Chemistry
129d
Cleared
Nov 09, 1992
SYNERMED HDL CHOLESTLEROL REAGENT KIT
Synermed, Inc.
Chemistry
69d
Cleared
Jan 09, 1992
IL TEST(TM) HDL CHOLESTEROL
Instrumentation Laboratory CO
Chemistry
76d
Cleared
Aug 16, 1991
HIGH DENSITY LIPOPROTEIN CHOLESTEROL
Creative Laboratory Products, Inc.
Chemistry
51d