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 Beckman Instruments, Inc..

230
Total
230
Cleared
87d
Avg days
1976
Since
230 devices
73–96 of 230
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 Jan 30, 1992
CHOLESTEROL REGEANT SET
K914160
Tech Intl. Co.
Chemistry · 135d
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 Aug 16, 1991
ENZYMATICS, INC., TOTAL CHOLESTEROL TEST
K911692
Enzymatics C/O Burditt,Bowles,Radzius & Ruberry
Chemistry · 122d
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
Cleared Mar 19, 1991
CHEMTRAK ACCUMETER CHOLESTEROL TEST
K905405
Chemtrak, Inc.
Chemistry · 106d
Cleared Mar 11, 1991
CHEMA CHOL CHOLESTEROL SYSTEM
K904031
Texas Intl. Laboratories, Inc.
Chemistry · 192d
Cleared Mar 06, 1991
CRP LIPID REAGENT TEST PACK
K905648
Cirrus Diagnostics, Inc.
Chemistry · 79d
Cleared Feb 26, 1991
ECLIPSE ICA CHOLESTEROL
K905145
Biotope, Inc.
Chemistry · 103d
Cleared Feb 26, 1991
CHOLESTAT (TM) WHOLE BLOOD CHOLESTEROL TEST
K910240
Crystal Diagnostics, Inc.
Chemistry · 35d
Cleared Dec 26, 1990
CHOLESTAT(TM) WHOLE BLOOD CHOLESTEROL TEST
K903126
Crystal Diagnostics, Inc.
Chemistry · 163d
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 Jun 12, 1990
SATELLITE C BLOOD CHOLESTEROL MONITORING SYSTEM
K896467
Medisense, Inc.
Chemistry · 211d
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