CHH · Class I · 21 CFR 862.1175

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

Leading manufacturers include Em Diagnostic Systems, Inc., Cholestech Corp. and Polymer Technology Systems, Inc..

230
Total
230
Cleared
87d
Avg days
1976
Since
230 devices
49–72 of 230
Cleared Jun 11, 1997
SYNCHRON SYSTEMS CHOLESTEROL (CHOL) REAGENT
K971505
Beckman Instruments, Inc.
Chemistry · 47d
Cleared Jun 04, 1997
PARAMAX CHOLESTEROL REAGENT
K964660
Dade Intl., Inc.
Chemistry · 196d
Cleared May 29, 1997
CHOL OR CHOLESTEROL
K971345
Carolina Liquid Chemistries Corp.
Chemistry · 49d
Cleared Sep 27, 1996
CHOLESTEROL-INCORPORATING DYNAMIC STAB TECH (DST)
K962890
Trace Scientific , Ltd.
Chemistry · 65d
Cleared May 02, 1996
ENA-C-T TOTAL CHOLESTEROL TEST
K960377
Actimed Laboratories, Inc.
Chemistry · 97d
Cleared Mar 06, 1996
ACCU-CHEK INSTANT PLUS CHOLOESTEROL TEST
K944458
Boehringer Mannheim Corp.
Chemistry · 541d
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 Mar 21, 1995
CHEM TRAK ACCUMETER
K943599
Chemtrak, Inc.
Chemistry · 258d
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 Oct 28, 1993
BECKMAN CHOLESTEROL REAGENT
K934046
Beckman-Diagnostic Systems Group
Chemistry · 70d
Cleared Mar 02, 1993
ACCUMETER(R) CHOLESTEROL SELF-TEST
K914432
Chemtrak, Inc.
Chemistry · 515d
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