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
121–144 of 230
Cleared May 30, 1985
T-CHO REAGENT
K852009
Alpkem Corp.
Chemistry · 23d
Cleared Jan 07, 1985
PERIDOCHROM CHOLESTEROL HIGH PERFORMANCE
K844655
Boehringer Mannheim Corp.
Chemistry · 39d
Cleared Jan 03, 1985
CHOLESTEROL REAGENT FOR DEMAND ANALYZER
K844242
Advanced Biomedical Methods, Inc.
Chemistry · 63d
Cleared Sep 28, 1984
PDA CHOLESTEROL
K843510
Abbott Laboratories
Chemistry · 22d
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 Mar 23, 1984
TOTAL CHOLESTEROL REAGENT SET
K840189
Preventive Diagnostics Corp.
Chemistry · 65d
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 19, 1983
MULTICHEM ENZYMATIC CHOLESTEROL SYS
K831700
Simmler, Inc.
Chemistry · 56d
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