LBR · Class I · 21 CFR 862.1475

FDA Product Code LBR: Ldl & Vldl Precipitation, Hdl

Leading manufacturers include Pointe Scientific, Inc.,, Genzyme Corp. and Boehringer Mannheim Corp..

66
Total
66
Cleared
71d
Avg days
1978
Since
66 devices
25–48 of 66
Cleared Jul 18, 1991
MAGNETIC HDL CHOLESTEROL TEST
K911906
Reference Diagnostics, Inc.
Chemistry · 79d
Cleared May 22, 1991
HDL CHOLESTEROL REAGENT
K911406
Genzyme Corp.
Chemistry · 54d
Cleared Dec 11, 1990
HDL-CHOLESTEROL PRECIPITANT 7773/7573/7473/7173
K905284
Amresco, Inc.
Chemistry · 18d
Cleared Aug 09, 1990
REFLOTRON HDL CHOLESTEROL TEST TABS
K902568
Boehringer Mannheim Corp.
Chemistry · 59d
Cleared Jul 31, 1990
COULTER HDL - CHOLESTEROL REAGENT
K902174
Coulter Corp.
Chemistry · 78d
Cleared Mar 09, 1990
ROCHE SEPARATING REAGENT FOR HDL CHOLESTEROL
K900120
Roche Diagnostic Systems, Inc.
Chemistry · 59d
Cleared Nov 08, 1989
HDL SINGLES
K895381
Trace America, Inc.
Chemistry · 71d
Cleared Apr 10, 1989
HDL CHOLESTEROL REAGENT
K891117
Pointe Scientific, Inc.,
Chemistry · 39d
Cleared Feb 17, 1989
HDL CHOLESTEROL REAGENT (PTA/MGCL2)
K890023
Sigma Diagnostics, Inc.
Chemistry · 44d
Cleared Feb 10, 1989
HDL CHOLESTEROL TEST
K885265
Em Diagnostic Systems, Inc.
Chemistry · 50d
Cleared Sep 13, 1988
IQ HDL CHOLESTEROL
K883353
Bd Becton Dickinson Vacutainer Systems Preanalytic
Chemistry · 35d
Cleared Jun 10, 1988
HDL CHOLESTEROL KIT
K881244
Trace Scientific , Ltd.
Chemistry · 79d
Cleared May 27, 1988
HDL CHOLESTEROL PRECIPITATING PROCEDURE
K881326
Data Medical Associates, Inc.
Chemistry · 59d
Cleared Feb 18, 1988
HDL CHOLESTEROL PRECIPITATING REAGENT
K880176
Tech-Co, Inc.
Chemistry · 34d
Cleared Jan 07, 1988
MULTICHEM HDL PRECIPITATING REAGENT #S0914
K874820
Simmler, Inc.
Chemistry · 44d
Cleared Jun 27, 1986
WORTHINGTON HDL PRECIPITATING REAGENT SET
K861926
Cooper Biomedical, Inc.
Chemistry · 39d
Cleared Jul 08, 1985
HDL CHOLESTEROL PRETREATMENT
K852350
American Monitor Corp.
Chemistry · 38d
Cleared Feb 13, 1984
HDL CHOLESTEROL PRETREATMENT
K834251
American Monitor Corp.
Chemistry · 68d
Cleared Feb 09, 1984
HDL EZ-TAB
K833160
Preventive Diagnostics Corp.
Chemistry · 146d
Cleared Jan 13, 1984
HDL EX-SEP PRECIPITATING REAGENT
K833431
Preventive Diagnostics Corp.
Chemistry · 100d
Cleared Mar 21, 1983
RAICHEM HDL-CHOLESTEROL REAGENT
K830207
Reagents Applications, Inc.
Chemistry · 59d
Cleared Jul 13, 1982
HDL PRECIPITANT REAGENT SET
K821203
Omega Medical Electronics
Chemistry · 77d
Cleared Dec 03, 1981
HDL CHOLESTEROL REAGENT SET
K812839
Anco Medical Reagents & Assoc.
Chemistry · 55d
Cleared Sep 24, 1981
HDL CHOLESTEROL REAGENT
K812574
Pointe Scientific, Inc.,
Chemistry · 15d