LBS · Class I · 21 CFR 862.1475

FDA Product Code LBS: Ldl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl

Leading manufacturers include Abbott Laboratories, Beckman Instruments, Inc. and Beckman Coulter, Inc..

80
Total
80
Cleared
84d
Avg days
1979
Since

FDA 510(k) Cleared Ldl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl Devices (Product Code LBS)

80 devices
1–24 of 80
Cleared May 14, 2010
HDL CHOLESTEROL (HDLX) ASSAY
K100010
Beckman Coulter, Inc.
Chemistry · 130d
Cleared Dec 09, 2005
AUTOMATED HDL CHOLESTEROL FLEX REAGENT CARTRIDGE, MODEL DF48A
K053157
Dade Behring, Inc.
Chemistry · 25d
Cleared Aug 25, 2005
ULTRA HDL
K051962
Abbott Laboratories
Chemistry · 37d
Cleared Sep 16, 2004
SYNCHRON SYSTEMS HDL CHOLESTEROL (HDL), SYNCHRON SYSTEMS LIPID PLUS CALIBRATORS 1 & 2, MODELS A15625/A16747
K042195
Beckman Coulter, Inc.
Chemistry · 34d
Cleared Jun 07, 2004
SYNCHRON SYSTEMS HDL CHOLESTEROL (HDLD) REAGENT
K040767
Beckman Coulter, Inc.
Chemistry · 74d
Cleared Dec 05, 2003
HDL-CHOLESTEROL PLUS 2ND GENERATION
K033610
Roche Diagnostics Corp.
Chemistry · 18d
Cleared Aug 08, 2001
MODIFICATION TO:COBAS INTEGRA HDL-CHOLESTEROL PLUS 2ND GENERATION
K012286
Roche Diagnostics Corp.
Chemistry · 19d
Cleared Aug 03, 1998
DIRECT HDL
K981224
Abbott Laboratories
Chemistry · 122d
Cleared Jun 11, 1998
HDL
K981580
Abbott Laboratories
Chemistry · 38d
Cleared Jun 16, 1997
ROCHE UNIMATE HDL DIRECT REAGENT, ROCHE CALIBRATOR HDL DIRECT
K971902
Roche Diagnostic Systems, Inc.
Chemistry · 24d
Cleared Oct 23, 1996
BOEHRINGER MANNHEIM DIRECT HDL-CHOLESTEROL
K963213
Boehringer Mannheim Corp.
Chemistry · 68d
Cleared Oct 14, 1993
BECKMAN HDL CHOLESTEROL REAGENT
K934045
Beckman Instruments, Inc.
Chemistry · 56d
Cleared Nov 29, 1989
SYNCHRON CX(R) SYSTEMS HDL CHOLESTEROL REAGENT
K895851
Beckman Instruments, Inc.
Chemistry · 57d
Cleared Jun 10, 1988
IQ HDL CHOLESTEROL
K881891
Bd Becton Dickinson Vacutainer Systems Preanalytic
Chemistry · 36d
Cleared Nov 24, 1987
EASY-TEST HDL CHOLESTEROL ITEM NUMBER 16683
K874397
Em Diagnostic Systems, Inc.
Chemistry · 27d
Cleared Aug 13, 1987
ANALYST(TM) LIPID ROTOR & HDL CALIBRATOR/CONTROL
K871265
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 135d
Cleared May 14, 1987
VISION (TM) HDL CHOLESTEROL
K871461
Abbott Laboratories
Chemistry · 30d
Cleared Feb 04, 1987
ASTRA SYSTEMS MULTIPLE CHEMISTRY MODULE
K864522
Beckman Instruments, Inc.
Chemistry · 79d
Cleared Aug 29, 1986
EMDS (TM) HDL CHOLESTEROL ITEM NO. 67679/95
K862845
Em Diagnostic Systems, Inc.
Chemistry · 31d
Cleared Jun 15, 1979
CHOLESTEROL KIT, HDL-DS
K790553
Beckman Instruments, Inc.
Chemistry · 88d

About Product Code LBS - Regulatory Context