CHH · Class I · 21 CFR 862.1175

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

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

230
Total
230
Cleared
87d
Avg days
1976
Since
230 devices
25–48 of 230
Cleared Aug 28, 1989
EMDS CHOLESTEROL (CHO), ITEM NUMBER 65410
K893916
Em Diagnostic Systems, Inc.
Chemistry · 90d
Cleared Feb 17, 1989
CHOLESTEROL TEST ITEM NUMBER: SR1011
K885023
Em Diagnostic Systems, Inc.
Chemistry · 74d
Cleared Jul 16, 1987
HDL CHOLESTEROL REAGENT
K872575
Sigma Chemical Co.
Chemistry · 16d
Cleared Mar 04, 1987
EASY-TEST CHOLESTEROL(CHOL) NUMBER 16607
K870407
Em Diagnostic Systems, Inc.
Chemistry · 29d
Cleared Aug 19, 1986
EMDS(TM) CHOLESTEROL TESTPACK, # 67685/95
K862707
Em Diagnostic Systems, Inc.
Chemistry · 34d
Cleared Jun 11, 1986
DIMENSION (TM) CLINICAL CHEMISTRY SYSTEM
K861700
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 37d
Cleared Jan 17, 1986
KODAK EKTACHEM HDL CHOLESTEROL KIT
K854426
Eastman Kodak Company
Chemistry · 73d
Cleared Oct 28, 1985
ASTRA SYSTEMS CHOLESTEROL REAGENT
K853854
Beckman Instruments, Inc.
Chemistry · 42d
Cleared Oct 04, 1985
QCA ENZYMATIC CHOLESTEROL
K853871
Bd Becton Dickinson Vacutainer Systems Preanalytic
Chemistry · 17d
Cleared Jan 07, 1985
PERIDOCHROM CHOLESTEROL HIGH PERFORMANCE
K844655
Boehringer Mannheim Corp.
Chemistry · 39d
Cleared Sep 28, 1984
PDA CHOLESTEROL
K843510
Abbott Laboratories
Chemistry · 22d
Cleared Sep 14, 1984
SYSTEMATE CHOLESTEROL 67222
K843327
Em Diagnostic Systems, Inc.
Chemistry · 18d
Cleared Aug 15, 1984
TDX REA CHOLESTEROL
K842320
Abbott Laboratories
Chemistry · 64d
Cleared May 09, 1984
MULTIPLE CHEM. MODULE FOR ANALYSIS
K841182
Beckman Instruments, Inc.
Chemistry · 50d
Cleared Aug 16, 1983
CHOLESTEROL HIGH PERFORMANCE-K
K832158
Boehringer Mannheim Corp.
Chemistry · 42d
Cleared Dec 09, 1982
CHOLESTEROL CHOD-PAP TEST
K823302
Boehringer Mannheim Corp.
Chemistry · 34d
Cleared Feb 18, 1982
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES
K820263
Eastman Kodak Company
Chemistry · 16d
Cleared Jan 09, 1981
LIQUID-STAT REAGENT FOR ASSAY OF CHOLES.
K803254
Beckman Instruments, Inc.
Chemistry · 17d
Cleared Mar 20, 1980
LIQUID-STAT LIQUID REAGENT
K800457
Beckman Instruments, Inc.
Chemistry · 20d
Cleared Jan 11, 1980
ACA HIGH DENSITY LIPOPROTEIN CHOLES.
K792509
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 37d
Cleared May 23, 1979
ENZYMATIC DETERMINATION
K790724
Sigma Chemical Co.
Chemistry · 40d
Cleared May 23, 1979
REAGENT SYSTEM #350HDL, SIGMA PROCEDURE
K790760
Sigma Chemical Co.
Chemistry · 36d
Cleared May 19, 1978
REAGENT SET HDL CHOLESTEROL
K780635
Boehringer Mannheim Corp.
Chemistry · 32d
Cleared Sep 13, 1977
MULTISTAT III CHOLESTEROL TEST
K771508
Instrumentation Laboratory CO
Chemistry · 39d