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 Boehringer Mannheim Corp..

230
Total
230
Cleared
87d
Avg days
1976
Since
230 devices
169–192 of 230
Cleared Nov 03, 1978
REAGENT SET, CHOLESTEROL
K781721
Medical Analysis Systems, Inc.
Chemistry · 23d
Cleared Jul 28, 1978
ENZYMATIC REAGENT FOR CHOLESTEROL MEAS
K781013
Coulter Electronics, Inc.
Chemistry · 42d
Cleared Jun 13, 1978
HDL CHOLESTEROL
K780659
Macomb Chemical Co.
Chemistry · 54d
Cleared Jun 06, 1978
AUTOZYME CHOLESTEROL-OXIDASE REAGENT KIT
K780783
J.T. Baker Chemical Co.
Chemistry · 25d
Cleared May 26, 1978
ACCESSORY HDL CHOLESTEROL REAGENT SET
K780638
The Dow Chemical Co.
Chemistry · 38d
Cleared May 19, 1978
ULTRACHEM ENZYMATIC CHOLESTEROL 65025
K780523
Harleco
Chemistry · 49d
Cleared May 19, 1978
REAGENT SET HDL CHOLESTEROL
K780635
Boehringer Mannheim Corp.
Chemistry · 32d
Cleared Oct 25, 1977
CHOLAR PRODU&T #17010
K771731
Hi Chem, Inc.
Chemistry · 41d
Cleared Oct 19, 1977
ENZYMATIC CHOLESTEROL
K771820
Macomb Chemical Co.
Chemistry · 26d
Cleared Sep 15, 1977
CHOLOPAP-HDL
K771586
Advanced Biomedical Methods, Inc.
Chemistry · 28d
Cleared Sep 13, 1977
MULTISTAT III CHOLESTEROL TEST
K771508
Instrumentation Laboratory CO
Chemistry · 39d
Cleared Sep 13, 1977
HOLESTEROL DELTA TEST ASSAY
K771582
Bd Becton Dickinson Vacutainer Systems Preanalytic
Chemistry · 26d
Cleared Jul 14, 1977
ENZYMATIC CHOLESTEROL REAGENT SET
K770909
American Monitor Corp.
Chemistry · 56d
Cleared Jun 08, 1977
CHOLESTEROL REAGENT
K770483
Smithkline Diagnostics, Inc.
Chemistry · 86d
Cleared Jun 02, 1977
CHOLESTEROL REAGENT SET
K770998
The Dow Chemical Co.
Chemistry
Cleared Jun 01, 1977
REAGENT SET, CHOLESTEROL, CAT NO. 4024
K770747
American Monitor Corp.
Chemistry · 40d
Cleared Feb 25, 1977
CHOLESTEROL TEST
K770265
Sclavo, Inc.
Chemistry · 14d
Cleared Jan 26, 1977
GLUCOSE ANALYZER 2 W/ CHOLES. REAG KT
K761136
Beckman Instruments, Inc.
Chemistry · 63d
Cleared Jan 25, 1977
GLUCOSE ANALYZER W/ CHOLESTEROL REAG KIT
K761089
Beckman Instruments, Inc.
Chemistry · 64d