LBS · Class I · 21 CFR 862.1475

FDA Product Code LBS: Ldl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl

Leading manufacturers include Beckman Instruments, Inc., Abbott Laboratories and Genzyme Corp..

80
Total
80
Cleared
84d
Avg days
1979
Since
80 devices
49–72 of 80
Cleared Nov 27, 1991
TECHNICON AXON(TM) SYSTEM METHODS ANYALYE HDL CHOL
K914511
Technicon Instruments Corp.
Chemistry · 49d
Cleared Dec 26, 1990
CHOLESTECH LIPID MONITORING SYSTEM,HDL CHOLESTEROL
K905296
Cholestech Corp.
Chemistry · 29d
Cleared Mar 09, 1990
IMMUNOTECH HDL-CHOLESTEROL TEST
K900036
Immunotech Corp.
Chemistry · 66d
Cleared Dec 27, 1989
CLINISTAT HDL CHOLESTEROL REAGENT TEST
K895139
Heraeus Kulzer, Inc.
Chemistry · 133d
Cleared Nov 29, 1989
SYNCHRON CX(R) SYSTEMS HDL CHOLESTEROL REAGENT
K895851
Beckman Instruments, Inc.
Chemistry · 57d
Cleared Aug 03, 1989
SERALYZER HDL CHOLESTEROL PROCEDURE USE W/STRIP
K893548
Heraeus Kulzer, Inc.
Chemistry · 87d
Cleared Jun 10, 1988
IQ HDL CHOLESTEROL
K881891
Bd Becton Dickinson Vacutainer Systems Preanalytic
Chemistry · 36d
Cleared Nov 24, 1987
EASY-TEST HDL CHOLESTEROL ITEM NUMBER 16683
K874397
Em Diagnostic Systems, Inc.
Chemistry · 27d
Cleared Aug 13, 1987
ANALYST(TM) LIPID ROTOR & HDL CALIBRATOR/CONTROL
K871265
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 135d
Cleared Jul 07, 1987
PARAMAX CHOLESTEROL REAGENT
K872050
American Dade
Chemistry · 40d
Cleared May 14, 1987
VISION (TM) HDL CHOLESTEROL
K871461
Abbott Laboratories
Chemistry · 30d
Cleared Feb 04, 1987
ASTRA SYSTEMS MULTIPLE CHEMISTRY MODULE
K864522
Beckman Instruments, Inc.
Chemistry · 79d
Cleared Aug 29, 1986
EMDS (TM) HDL CHOLESTEROL ITEM NO. 67679/95
K862845
Em Diagnostic Systems, Inc.
Chemistry · 31d
Cleared Aug 27, 1984
HIGH DENSITY LIPOPROTEIN PRECIPITATIN
K843029
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 26d
Cleared Apr 13, 1984
HDL EZ-TZ3 CHOLESTEROL REAGENT KIT
K840677
Preventive Diagnostics Corp.
Chemistry · 58d
Cleared Apr 04, 1984
PDC HDL EZ-SEP CHOLESTEROL REAGENT
K840676
Preventive Diagnostics Corp.
Chemistry · 49d
Cleared Nov 27, 1981
HDL-C EIKEN
K813192
Syn-Kit, Inc.
Chemistry · 10d
Cleared Sep 09, 1980
HDL CHOLESTEROL TEST KIT
K801726
Mallinckrodt Critical Care
Chemistry · 47d
Cleared Jun 17, 1980
CENTRIFICHEM HDL CHOLESTEROL
K801133
Union Carbide Corp.
Chemistry · 36d
Cleared Dec 06, 1979
COULTER HDL CHOLESTEROL REAG. SYSTEM
K792319
Coulter Electronics, Inc.
Chemistry · 17d
Cleared Nov 13, 1979
DADE HIGH DENSITY LIPOPROTEIN CHOLESTERO
K792183
Dade, Baxter Travenol Diagnostics, Inc.
Chemistry · 15d
Cleared Oct 17, 1979
TECHNICON HDL CHOLESTEROL METHOD
K791990
Technicon Instruments Corp.
Chemistry · 14d
Cleared Jun 15, 1979
CHOLESTEROL KIT, HDL-DS
K790553
Beckman Instruments, Inc.
Chemistry · 88d
Cleared Mar 21, 1979
DIAGNOSTIC SET, LIPO-FRAX
K790281
Analytical Products, Inc.
Chemistry · 36d