CHH · Class I · 21 CFR 862.1175

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

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

230
Total
230
Cleared
87d
Avg days
1976
Since
230 devices
145–168 of 230
Cleared Jun 01, 1982
ENZYMATIC CHOLESTERAL OXIDASE #650550
K821441
Emd Chemicals, Inc.
Chemistry · 19d
Cleared May 05, 1982
CHOLESTEZYME-V EIKEN
K821105
Syn-Kit, Inc.
Chemistry · 15d
Cleared Apr 26, 1982
ENZYMATIC CHOLESTEROL KIT
K820951
Anco Medical Reagents & Assoc.
Chemistry · 20d
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
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 Jul 28, 1980
YSI MODELS 23C & 23CM HDL & TOTAL CHOLES
K801285
Yellow Springs Instrument Co., Inc.
Chemistry · 60d
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 Feb 21, 1980
LINEAR ENZYMATIC CHOLESTEROL SYSTEM
K800199
Simmler, Inc.
Chemistry · 22d
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 Sep 04, 1979
ENZYMATIC REAGENT SET, 4X250 ML.
K791511
Macomb Chemical Co.
Chemistry · 40d
Cleared Jun 28, 1979
AUTO ENZYMATIC CHOLESTEROL
K790947
Macomb Chemical Co.
Chemistry · 41d
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