LBR · Class I · 21 CFR 862.1475

FDA Product Code LBR: Ldl & Vldl Precipitation, Hdl

Leading manufacturers include Genzyme Corp., Pointe Scientific, Inc., and Merchant House Scientific.

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 Jan 28, 2015
LDLC3 LDL-Cholesterol Gen.3
K143691
Roche Diagnostics Operations (Rdo)
Chemistry · 35d
Cleared Jan 22, 2008
DIAZYME LDL-CHOLESTEROL REAGENT, CALIBRATOR AND CONTROLS
K072523
General Atomics
Chemistry · 137d
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 12, 1999
ATAC DIRECT HDL CHOLESTEROL REAGENT AND ATAC HDL-C CALIBRATOR KITS
K992029
Elan Diagnostics
Chemistry · 57d
Cleared Aug 05, 1999
AUTOHDL CHOLESTEROL REAGENT SET
K992002
Pointe Scientific, Inc.,
Chemistry · 51d
Cleared Jul 09, 1999
ATAC-PAK DIRECT HDL CHOLESTEROL REAGENT AND ATAC HDL-C CALIBRATOR KITS
K991789
Elan Holdings, Inc.
Chemistry · 45d
Cleared May 28, 1999
MTM BIOSCANNER HDL, MODEL # BSA450, BSA460, BSA470
K990247
Polymer Technology Systems, Inc.
Chemistry · 122d
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 Jun 18, 1997
N-GENEOUS LDL CHOLESTEROL REAGENT, N-GENEOUS LDL CHOLESTEROL CALIBRATOR, GENZYME LDL CHOLESTEROL CONTROL SET
K971573
Genzyme Corp.
Chemistry · 49d
Cleared Mar 13, 1997
TRACE HDL CHOLESTEROL - AUTOMATED (HOMOGEN
K962723
Trace America, Inc.
Chemistry · 241d
Cleared Aug 19, 1996
N-GENEOUS HDL CHOLESTEROL KIT/CHOLESTEROL CALIBRATOR
K962186
Genzyme Corp.
Chemistry · 74d
Cleared Dec 11, 1995
HDL PRECIPITATING REAGENT
K954179
Schiapparelli Biosystems, Inc.
Chemistry · 96d
Cleared Aug 02, 1995
MAGNETIC HDL CHOLESTEROL TEST
K944975
Reference Diagnostics, Inc.
Chemistry · 295d
Cleared Sep 06, 1994
PBI PLUS HDL PRECIPITATING REAGENT
K941744
Merchant House Scientific
Chemistry · 152d
Cleared Dec 10, 1993
HDL-CHOLESTRAL(DEXTRAN SULFATE/MAGNESIUM)
K932766
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 185d
Cleared Dec 09, 1993
SPINPRO HDL PRECIPITATING REAGENT
K934961
Merchant House Scientific
Chemistry · 55d
Cleared Dec 07, 1993
SPINPRO HDL PRECIPITATING REAGENT
K934801
Merchant House Scientific
Chemistry · 61d
Cleared Nov 16, 1993
INTERSECT SYSTEMS HDL CHOLESTEROL REAGENT SET
K934039
Intersect Systems, Inc.
Chemistry · 90d

About Product Code LBR - Regulatory Context