CHH · Class I · 21 CFR 862.1175

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

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

230
Total
230
Cleared
87d
Avg days
1976
Since
230 devices
25–48 of 230
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 Dec 18, 1991
ABBOTT QUICKSTART CHOLESTEROL TEST
K913565
Em Diagnostic Systems, Inc.
Chemistry · 131d
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 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 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 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