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 Beckman Instruments, Inc..

230
Total
230
Cleared
87d
Avg days
1976
Since
230 devices
97–120 of 230
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 Apr 13, 1987
CHOLESTEROL DETERMINATION
K871260
Biochemical Trade, Inc.
Chemistry · 13d
Cleared Mar 13, 1987
INTERSECT SYSTEMS ENZYMATIC CHOLESTEROL REAGENT
K870828
Intersect Systems, Inc.
Chemistry · 10d
Cleared Mar 04, 1987
EASY-TEST CHOLESTEROL(CHOL) NUMBER 16607
K870407
Em Diagnostic Systems, Inc.
Chemistry · 29d
Cleared Jan 13, 1987
PEG 6,000
K863103
J. D. Assoc.
Chemistry · 153d
Cleared Dec 04, 1986
U.S. DIAGNOSTICS SERUM CHOLESTEROL TEST
K864081
U. S. Diagnostics, Inc.
Chemistry · 45d
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 Sep 25, 1986
CHOLESTEROL-E (TOTAL)
K863062
J. D. Assoc.
Chemistry · 44d
Cleared Sep 11, 1986
CHOLESTEROL-E (FREE)
K863064
J. D. Assoc.
Chemistry · 30d
Cleared Sep 09, 1986
CHOLESTEROL-E FAST (TOTAL)
K863063
J. D. Assoc.
Chemistry · 28d
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 Jan 14, 1986
ENZYMATIC CHOLESTROL REAGENT SET
K855187
Technostics Intl.
Chemistry · 19d
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