LBS · Class I · 21 CFR 862.1475

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

Leading manufacturers include Beckman Instruments, Inc., Abbott Laboratories and Genzyme Corp..

80
Total
80
Cleared
84d
Avg days
1979
Since
80 devices
25–48 of 80
Cleared Jul 25, 2002
ULTRA N-GENEOUS HDL CHOLESTEROL REAGENT 1/REAGENT2
K021316
Genzyme Corp.
Chemistry · 91d
Cleared Jul 19, 2002
JAS HDL CHOLESTEROL (AUTOMATED) REAGENT
K021671
Jas Diagnostics, Inc.
Chemistry · 59d
Cleared Feb 08, 2002
OLYMPUS HDL CHOLESTEROL REAGENT
K014015
Olympus America, Inc.
Chemistry · 65d
Cleared Feb 08, 2002
OLYMPUS LDL CHOLESTEROL REAGENT, OLYMPUS LDL CHOLESTEROL CALIBRATOR, OLYMPUS HDL/LDL CHOLESTEROL CONTROL SERA
K014032
Olympus America, Inc.
Chemistry · 64d
Cleared Aug 08, 2001
MODIFICATION TO:COBAS INTEGRA HDL-CHOLESTEROL PLUS 2ND GENERATION
K012286
Roche Diagnostics Corp.
Chemistry · 19d
Cleared Aug 19, 1999
LDL CHOLESTEROL, PRODUCT NO'S, 124-01, CH102-01
K991664
A.P. Total Care, Inc.
Chemistry · 97d
Cleared Aug 10, 1999
HDL CHOLESTEROL, PRODUCT NO'S 124-01, CH102-01
K991665
A.P. Total Care, Inc.
Chemistry · 88d
Cleared Jun 18, 1999
DIRECT HDL-CHOLESTEROL REAGENT
K990581
Kamiya Biomedical Co.
Chemistry · 115d
Cleared Sep 15, 1998
HDLC PRECIPITATING REAGENT
K982539
Ac Biochemicals, Inc.
Chemistry · 56d
Cleared Aug 03, 1998
DIRECT HDL
K981224
Abbott Laboratories
Chemistry · 122d
Cleared Jul 30, 1998
DIRECT HDL-CHOLESTROL LIQUID
K982341
Randox Laboratories, Ltd.
Chemistry · 38d
Cleared Jul 14, 1998
CARESIDE HDL-CHOLESTEROL
K981899
Exigent Diagnostics, Inc.
Chemistry · 43d
Cleared Jun 11, 1998
HDL
K981580
Abbott Laboratories
Chemistry · 38d
Cleared Dec 22, 1997
RDI HOMOGENEOUS HDL CHOLESTEROL TEST
K973988
Reference Diagnostics, Inc.
Chemistry · 62d
Cleared Jul 22, 1997
EZ HDL CHOLESTEROL REAGENT(PROCEDURE 354)/EZ HDL CALIBRATOR (354-5)
K972041
Sigma Diagnostics, Inc.
Chemistry · 50d
Cleared Jun 16, 1997
LIQUID N-GENEOUS HDL CHOLESTEROL KIT/CALIBRATOR
K971162
Genzyme Corp.
Chemistry · 77d
Cleared Jun 16, 1997
N-GENEOUS HDL CHOLESTEROL KIT/CHOLESTEROL CALIBRATOR
K971190
Genzyme Corp.
Chemistry · 77d
Cleared Jun 16, 1997
ROCHE UNIMATE HDL DIRECT REAGENT, ROCHE CALIBRATOR HDL DIRECT
K971902
Roche Diagnostic Systems, Inc.
Chemistry · 24d
Cleared Jun 06, 1997
BOEHRINGER MANNHEIM DIRECT HDL-CHOLESTEROL
K970735
Randox Laboratories, Ltd.
Chemistry · 108d
Cleared May 21, 1997
ACE HDL-C REAGENT
K971526
Schiapparelli Biosystems, Inc.
Chemistry · 23d
Cleared Oct 23, 1996
BOEHRINGER MANNHEIM DIRECT HDL-CHOLESTEROL
K963213
Boehringer Mannheim Corp.
Chemistry · 68d
Cleared Nov 24, 1995
CHOLESTECH LDX SYSTEM
K954778
Cholestech Corp.
Chemistry · 66d
Cleared Dec 07, 1994
HDL QVET
K943028
Prisma Systems
Chemistry · 163d
Cleared Oct 14, 1993
BECKMAN HDL CHOLESTEROL REAGENT
K934045
Beckman Instruments, Inc.
Chemistry · 56d