CHH · Class I · 21 CFR 862.1175

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

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

230
Total
230
Cleared
87d
Avg days
1976
Since
230 devices
97–120 of 230
Cleared Mar 31, 1981
ENZYMATIC CHOLESTEROL
K810673
Pointe Scientific, Inc.,
Chemistry · 19d
Cleared Feb 26, 1981
CHOLESTEROL REAGENT
K810405
Gilford Diagnostics
Chemistry · 8d
Cleared Jan 09, 1981
LIQUID-STAT REAGENT FOR ASSAY OF CHOLES.
K803254
Beckman Instruments, Inc.
Chemistry · 17d
Cleared Dec 10, 1980
AMES SERA-PAK CHOLESTEROL REAGENT KIT
K802743
Miles Laboratories, Inc.
Chemistry · 37d
Cleared Apr 24, 1980
CENTRIFICHEM CHOLESTEROL
K800765
Union Carbide Corp.
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 Dec 27, 1979
CHEM-STRATE CHOLESTEROL
K792478
General Diagnostics
Chemistry · 24d
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 07, 1979
CHOLESTEROL REAGENT, AUTOMATED ENZYMATIC
K790556
Calbiochem-Behring Corp.
Chemistry · 49d
Cleared Nov 22, 1978
REAGENT, HDL
K781740
Fisher Scientific Co., LLC
Chemistry · 36d
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 06, 1978
AUTOZYME CHOLESTEROL-OXIDASE REAGENT KIT
K780783
J.T. Baker Chemical Co.
Chemistry · 25d
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 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 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