MRR · Class I · 21 CFR 862.1475

FDA Product Code MRR: System, Test, Low Density, Lipoprotein

Leading manufacturers include Reference Diagnostics, Inc., Genzyme Corp. and Schiapparelli Biosystems, Inc..

31
Total
31
Cleared
139d
Avg days
1990
Since
31 devices
25–31 of 31
Cleared Nov 20, 1996
RDI LIPIDIRECT MAGNETIC LDL REAGENT
K964064
Reference Diagnostics, Inc.
Chemistry · 41d
Cleared May 24, 1996
EKTACHEM DT LDL CHOLESTEROL KIT
K955904
Johnson & Johnson Clinical Diagnostics, Inc.
Chemistry · 147d
Cleared Mar 15, 1995
DIRECT LDL CHOLESTEROL IMMUNOSEPARATION REAGENT KIT
K943150
Genzyme Corp.
Chemistry · 258d
Cleared Jan 06, 1993
DIRECT LDL CHOLES IMMUNOSEPARATION REAGENT
K924674
Genzyme Corp.
Chemistry · 112d
Cleared Mar 19, 1990
LIPIDIRECT LOW DENSITY LIPOPROTEIN CHOLESTEROL TES
K893740
Reference Diagnostics, Inc.
Chemistry · 306d