CHH · Class I · 21 CFR 862.1175

FDA Product Code CHH: Enzymatic Esterase--oxidase, Cholesterol

Leading manufacturers include Cholestech Corp., Em Diagnostic Systems, Inc. and Boehringer Mannheim Corp..

230
Total
230
Cleared
87d
Avg days
1976
Since
230 devices
49–72 of 230
Cleared Aug 23, 1995
DMA TOTAL CHOLESTEROL PROCEDURE
K946161
Data Medical Associates, Inc.
Chemistry · 247d
Cleared Jul 20, 1995
BOEHRINGER MANNHEIM CHOLESTEROL ASSAY
K952127
Boehringer Mannheim Corp.
Chemistry · 73d
Cleared Apr 13, 1995
PICCOLO(TM) PRIMARY HEALTH PANEL REAGENT ROTOR
K950164
Abaxis, Inc.
Chemistry · 86d
Cleared Feb 22, 1995
TOTAL CHOLESTEROL AND HDL CHOLESTEROL PANEL
K946063
Cholestech Corp.
Chemistry · 99d
Cleared Feb 22, 1995
TOTAL CHOLESTEROL CASSETTE
K946064
Cholestech Corp.
Chemistry · 99d
Cleared Feb 22, 1995
TOTAL CHOLESTEROLM HDL CHOLESTEROL AND TRIGLYCERIDES PANEL
K946065
Cholestech Corp.
Chemistry · 99d
Cleared Feb 22, 1995
TOTAL CHOLESTEROL, HDL CHOLESTEROL AND GLUCOSE PANEL
K946066
Cholestech Corp.
Chemistry · 99d
Cleared Feb 22, 1995
TOTAL CHOLESTEROL, HDL CHOLESTEROL, TRIGLYCERIDES AND GLUCOSE PANEL
K946067
Cholestech Corp.
Chemistry · 99d
Cleared Jan 27, 1995
CHOLESTEROL QVET
K943027
Prisma Systems
Toxicology · 214d
Cleared Oct 31, 1994
ROCHE REAGENT
K941573
Roche Diagnostic Systems, Inc.
Chemistry · 214d
Cleared Jan 10, 1994
CHOLESTEROL ENZYMATIC ENDPOINT
K923504
Randox Laboratories, Ltd.
Chemistry · 544d
Cleared Dec 16, 1993
CHOLESTEROL (CHOL) TEST ITEM NO. 65410
K935136
Em Diagnostic Systems, Inc.
Chemistry · 49d
Cleared Feb 08, 1993
OLYMPUS CHOLESTEROL REAGENT
K925603
Olympus Corp.
Chemistry · 95d
Cleared Jan 28, 1993
CHOLESTEROL TEST ITEM# 42374/93, 42322/R1
K924508
Em Diagnostic Systems, Inc.
Chemistry · 146d
Cleared Nov 18, 1992
OLYMPUS CHOLESTEROL REAGENT
K922231
Olympus Corp.
Chemistry · 190d
Cleared Oct 26, 1992
CHOLESTEROL TEST
K923733
Em Diagnostic Systems, Inc.
Chemistry · 91d
Cleared Sep 09, 1992
KING DIAGNOSTICS CHOLESTEROL REAGENT
K923128
King Diagnostics, Inc.
Chemistry · 75d
Cleared Jun 24, 1992
CHOLESTECH LIPID MONITORING SYSTEM, TOTAL CHOLESTE
K922612
Cholestech Corp.
Chemistry · 22d
Cleared Dec 18, 1991
ABBOTT QUICKSTART CHOLESTEROL TEST
K913565
Em Diagnostic Systems, Inc.
Chemistry · 131d
Cleared Oct 30, 1991
CHOLESTECH LIPID MONIT SYST, TOTAL CHOL/TRIG PANEL
K914469
Cholestech Corp.
Chemistry · 23d
Cleared Sep 27, 1991
KING DIAGNOSTICS CHOLESTEROL REAGENT STRIP TEST
K912499
King Diagnostics, Inc.
Chemistry · 114d
Cleared Aug 28, 1991
PROACT CHOLESTEROL SYSTEMS
K912212
Boehringer Mannheim Corp.
Chemistry · 100d
Cleared Jul 30, 1991
CHOLESTECH LIPID MONITORING SYS.
K912136
Cholestech Corp.
Chemistry · 77d
Cleared May 15, 1991
CHOLESTECH L.D.X. LIPID ANALYZER, MODIFICATION
K911578
Cholestech Corp.
Chemistry · 49d