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
73–96 of 230
Cleared Sep 14, 1984
SYSTEMATE CHOLESTEROL 67222
K843327
Em Diagnostic Systems, Inc.
Chemistry · 18d
Cleared Aug 17, 1984
CHOLESTEROL ASSSAY KIT
K842160
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 79d
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 May 01, 1984
CHOLESTEROL REAGENT SET ENZYMATIC
K841053
Medical Specialties, Inc.
Chemistry · 50d
Cleared Apr 04, 1984
PARAMAX CHOLESTEROL REAGENT
K840776
American Dade
Chemistry · 56d
Cleared Mar 30, 1984
DURAZYME CHOLESTEROL
K840368
American Monitor Corp.
Chemistry · 63d
Cleared Oct 14, 1983
FLOW-PAC SHOLESTEROL REAGENT SET
K832780
American Research Products Co.
Chemistry · 59d
Cleared Aug 16, 1983
CHOLESTEROL HIGH PERFORMANCE-K
K832158
Boehringer Mannheim Corp.
Chemistry · 42d
Cleared Jul 22, 1983
CHOLESTEROL-ENZYMATIC REAGENT SET
K831863
Stanbio Laboratory
Chemistry · 42d
Cleared Jul 18, 1983
WAKO CHOLESTEROL CII
K831687
Wako Chemicals USA, Inc.
Pathology · 55d
Cleared Apr 18, 1983
WAKO FREE CHOLESTEROL C TEST
K830761
Wako Chemicals USA, Inc.
Chemistry · 39d
Cleared Apr 05, 1983
ULTRA CHEM ENZYMATIC CHOLESTEROL OXIDA
K830239
Emd Chemicals, Inc.
Chemistry · 70d
Cleared Feb 28, 1983
ULTRA CHEM ENZYMATIC CHOLESTEROL OXIDASE
K830309
Emd Chemicals, Inc.
Chemistry · 28d
Cleared Dec 22, 1982
ULTRACHEM ENZYMATIC CHOLESTEROL OXIDASE
K823354
Emd Chemicals, Inc.
Chemistry · 47d
Cleared Dec 09, 1982
CHOLESTEROL CHOD-PAP TEST
K823302
Boehringer Mannheim Corp.
Chemistry · 34d
Cleared Oct 21, 1982
NEW ENZYMATIC SINGLE REAGENT FREE CHOL.
K822417
Sclavo, Inc.
Chemistry · 71d
Cleared Sep 14, 1982
ULTRACHEM ENZYMATIC CHOL. OXIDASE
K822418
Emd Chemicals, Inc.
Chemistry · 34d
Cleared Jun 01, 1982
ENZYMATIC CHOLESTERAL OXIDASE #650550
K821441
Emd Chemicals, Inc.
Chemistry · 19d
Cleared Mar 11, 1982
ENZYMATIC CHOLESTEROL REAGENT SYSTEM
K820473
American Monitor Corp.
Chemistry · 20d
Cleared Feb 18, 1982
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES
K820263
Eastman Kodak Company
Chemistry · 16d
Cleared Nov 10, 1981
ULTRACHEM E-CHOL, ITEM #65025
K813039
Harleco
Chemistry · 13d
Cleared Aug 12, 1981
FAST CHOLES-CINET
K812091
Sclavo, Inc.
Chemistry · 20d
Cleared Aug 12, 1981
SERALYZER
K812100
Miles Laboratories, Inc.
Chemistry · 19d