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
73–96 of 230
Cleared Oct 01, 1990
SYNERMED CHOLESTEROL REAGENT KIT
K903015
Synermed, Inc.
Chemistry · 83d
Cleared Sep 25, 1990
LIQUID STABLE CHOLESTEROL REAGENT KIT
K902678
Trace Scientific , Ltd.
Chemistry · 98d
Cleared Aug 09, 1990
CHOLESTEROL (RATE) REAGENT
K902098
Sigma Chemical Co.
Chemistry · 93d
Cleared Jul 24, 1990
L.D.X LIPID MONITORING SYSTEM
K901900
Cholestech Corp.
Chemistry · 88d
Cleared Mar 29, 1990
COULTER CHOLESTEROL REAGENT
K897162
Coulter Electronics, Inc.
Chemistry · 91d
Cleared Mar 29, 1990
EMDS CHOLESTEROL (CHO), ITEM NUMBERS 65410
K900850
Em Diagnostic Systems, Inc.
Chemistry · 35d
Cleared Mar 06, 1990
IMMUNOTECH CHOLESTEROL TEST
K897036
Immunotech Corp.
Chemistry · 78d
Cleared Feb 16, 1990
COBAS READY CHOLESTEROL REAGENT
K896239
Roche Diagnostic Systems, Inc.
Chemistry · 109d
Cleared Oct 02, 1989
VISION WHOLE BLOOD HDL CHOLESTEROL
K895158
Abbott Laboratories
Chemistry · 53d
Cleared Aug 28, 1989
EMDS CHOLESTEROL (CHO), ITEM NUMBER 65410
K893916
Em Diagnostic Systems, Inc.
Chemistry · 90d
Cleared Jun 19, 1989
CHOLESTEROL REAGENT SET
K893479
American Monitor Corp.
Chemistry · 46d
Cleared Jun 16, 1989
AMRESCO CHOLESTEROL REAGENTS, PROD. # 7325
K891922
American Research Products Co.
Chemistry · 81d
Cleared Jun 07, 1989
CLA 200 CHEMPRO(R) LIPID ANALYZER
K892238
Johnson & Johnson Professionals, Inc.
Chemistry · 64d
Cleared May 03, 1989
TOTAL CHOLESTEROL REAGENT
K890334
Alpkem Corp.
Chemistry · 100d
Cleared Apr 10, 1989
EXTEND INTENDED USE FOR ENZYME RINSE CONCENTRATE
K890990
Hichem Diagnostics
Chemistry · 42d
Cleared Mar 10, 1989
CLINISTAT CHOLESTEROL REAGENT TEST
K884757
Heraeus Kulzer, Inc.
Chemistry · 116d
Cleared Feb 17, 1989
CHOLESTEROL TEST ITEM NUMBER: SR1011
K885023
Em Diagnostic Systems, Inc.
Chemistry · 74d
Cleared Dec 16, 1988
HDL-CHOLESTEROL PRECIPITATING REAGENT
K883543
Medical Analysis Systems, Inc.
Chemistry · 119d
Cleared Oct 31, 1988
HI CHEM KINETIC CHOLESTEROL REAGENT #88218
K883844
Hichem Diagnostics
Chemistry · 49d
Cleared Apr 28, 1988
CHOLESTEROL
K880237
Tech-Neal Scientific, Inc.
Chemistry · 99d
Cleared Mar 01, 1988
(SKD) CHOLESTEROL TEST KIT
K875131
Smithkline Diagnostics, Inc.
Chemistry · 77d
Cleared Mar 01, 1988
WAKO(TM) AUTOKIT CHOLESTEROL
K880311
Wako Chemicals USA, Inc.
Chemistry · 36d
Cleared Aug 21, 1987
BIOTROL CHOLESTEROL ENZYMATIQUE COLOR
K872930
Biotrol, USA, Inc.
Chemistry · 25d
Cleared Jul 16, 1987
CHOLESTEROL REAGENT
K872295
Sigma Diagnostics, Inc.
Chemistry · 30d