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
49–72 of 230
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 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
Cleared Jul 16, 1987
HDL CHOLESTEROL REAGENT
K872575
Sigma Chemical Co.
Chemistry · 16d
Cleared Apr 22, 1987
CHOLESTEROL (TOTAL) ANALYSIS PRODUCTS
K870928
Electro-Nucleonics Laboratories, Inc.
Chemistry · 44d
Cleared Mar 04, 1987
EASY-TEST CHOLESTEROL(CHOL) NUMBER 16607
K870407
Em Diagnostic Systems, Inc.
Chemistry · 29d
Cleared Nov 24, 1986
CHOLESTEROL
K863927
Tech-Co, Inc.
Chemistry · 47d
Cleared Sep 29, 1986
CHOLESTEROL PROCEDURE
K863252
Data Medical Associates, Inc.
Chemistry · 35d
Cleared Aug 19, 1986
EMDS(TM) CHOLESTEROL TESTPACK, # 67685/95
K862707
Em Diagnostic Systems, Inc.
Chemistry · 34d
Cleared Jul 16, 1986
FAST CHOLESTEROL (TOTAL CHOLESTEROL TEST)
K862507
Sclavo, Inc.
Chemistry · 15d
Cleared Jun 13, 1986
CHOLESTEROL PROCEDURE
K861659
Data Medical Associates, Inc.
Chemistry · 44d
Cleared Jun 11, 1986
DIMENSION (TM) CLINICAL CHEMISTRY SYSTEM
K861700
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 37d
Cleared Apr 11, 1986
ENZYMATIC CHOLESTEROL REAGENT (SINGLE VIAL)
K860717
Trace Scientific , Ltd.
Chemistry · 44d
Cleared Jan 28, 1986
TOTAL CHOLESTEROL REAGENT SET
K855028
Sterling Diagnostics, Inc.
Chemistry · 43d
Cleared Jan 17, 1986
KODAK EKTACHEM HDL CHOLESTEROL KIT
K854426
Eastman Kodak Company
Chemistry · 73d
Cleared Nov 25, 1985
IN-VITRO TEST FOR THE DETERMINATION OF CHOLESTEROL
K854179
Clinical Data, Inc.
Chemistry · 41d
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 Jul 23, 1985
CHOLESTEROL METHOD
K852863
Catachem, Inc.
Chemistry · 15d
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