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Panels › Clinical Chemistry › Product code LBS · Class 1

Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl

Regulation 862.1475

0510(k)s in 12 months (80 all time)
1recalls in 12 months (9 all time)
8recalls that name a 510(k)
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Top companies in LBS

Company510(k)sRecalls
Abbott Laboratories40
Beckman Coulter, Inc.31
Beckman Instruments, Inc.40
Ortho-Clinical Diagnostics, Inc.22
Genzyme Corp.30
Randox Laboratories, Ltd.30
Roche Diagnostics Corp.21
A.P. Total Care, Inc.20
Cholestech Corp.20
Diagnostic Chemicals , Ltd.20
Decided510(k)Device and applicantCode
May 1, 1995K943279ACCUMETER HDL CHOLESTEROL TEST
Chemtrak, Inc.
LBS
Dec 7, 1994K943028HDL QVET
Prisma Systems
LBS
Oct 14, 1993K934045BECKMAN HDL CHOLESTEROL REAGENT
Beckman Instruments, Inc.
LBS
Nov 27, 1991K914511TECHNICON AXON(TM) SYSTEM METHODS ANYALYE HDL CHOL
Technicon Instruments Corp.
LBS
Dec 26, 1990K905296CHOLESTECH LIPID MONITORING SYSTEM,HDL CHOLESTEROL
Cholestech Corp.
LBS
Mar 9, 1990K900036IMMUNOTECH HDL-CHOLESTEROL TEST
Immunotech Corp.
LBS
Dec 27, 1989K895139CLINISTAT HDL CHOLESTEROL REAGENT TEST
Heraeus Kulzer, Inc.
LBS
Nov 29, 1989K895851SYNCHRON CX(R) SYSTEMS HDL CHOLESTEROL REAGENT
Beckman Instruments, Inc.
LBS
Aug 31, 1989K894057QUIKREAD WHOLE BLOOD HDL-CHOLESTEROL TEST KIT
Photec Diagnostics, Inc.
LBS
Aug 3, 1989K893548SERALYZER HDL CHOLESTEROL PROCEDURE USE W/STRIP
Heraeus Kulzer, Inc.
LBS
Jun 10, 1988K881891IQ HDL CHOLESTEROL
Bd Becton Dickinson Vacutainer Systems Preanalytic
LBS
Nov 24, 1987K874397EASY-TEST HDL CHOLESTEROL ITEM NUMBER 16683
Em Diagnostic Systems, Inc.
LBS
Aug 13, 1987K871265ANALYST(TM) LIPID ROTOR & HDL CALIBRATOR/CONTROL
E.I. Dupont DE Nemours & Co., Inc.
LBS
Jul 7, 1987K872050PARAMAX CHOLESTEROL REAGENT
American Dade
LBS
May 14, 1987K871461VISION (TM) HDL CHOLESTEROL
Abbott Laboratories
LBS
Feb 4, 1987K864522ASTRA SYSTEMS MULTIPLE CHEMISTRY MODULE
Beckman Instruments, Inc.
LBS
Sep 29, 1986K861244HDL/CHOLESTEROL TEST SYSTEM
Chrometrics Laboratories, Inc.
LBS
Aug 29, 1986K862845EMDS (TM) HDL CHOLESTEROL ITEM NO. 67679/95
Em Diagnostic Systems, Inc.
LBS
Aug 27, 1984K843029HIGH DENSITY LIPOPROTEIN PRECIPITATIN
Diagnostic Chemicals, Ltd. (Usa)
LBS
Apr 13, 1984K840677HDL EZ-TZ3 CHOLESTEROL REAGENT KIT
Preventive Diagnostics Corp.
LBS
Apr 4, 1984K840676PDC HDL EZ-SEP CHOLESTEROL REAGENT
Preventive Diagnostics Corp.
LBS
Nov 27, 1981K813192HDL-C EIKEN
Syn-Kit, Inc.
LBS
Sep 16, 1980K801834WAKO HDL CHOLESTEROL TEST
Wako Pure Chemical Industries, Ltd.
LBS
Sep 9, 1980K801726HDL CHOLESTEROL TEST KIT
Mallinckrodt Critical Care
LBS
Jun 17, 1980K801133CENTRIFICHEM HDL CHOLESTEROL
Union Carbide Corp.
LBS
Dec 6, 1979K792319COULTER HDL CHOLESTEROL REAG. SYSTEM
Coulter Electronics, Inc.
LBS
Nov 13, 1979K792183DADE HIGH DENSITY LIPOPROTEIN CHOLESTERO
Dade, Baxter Travenol Diagnostics, Inc.
LBS
Oct 17, 1979K791990TECHNICON HDL CHOLESTEROL METHOD
Technicon Instruments Corp.
LBS
Jun 15, 1979K790553CHOLESTEROL KIT, HDL-DS
Beckman Instruments, Inc.
LBS
Mar 21, 1979K790281DIAGNOSTIC SET, LIPO-FRAX
Analytical Products, Inc.
LBS

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