LBR · Class I · 21 CFR 862.1475

FDA Product Code LBR: Ldl & Vldl Precipitation, Hdl

Leading manufacturers include Pointe Scientific, Inc.,, Ortho-Clinical Diagnostics, Inc. and Roche Diagnostic Systems, Inc..

66
Total
66
Cleared
71d
Avg days
1978
Since
66 devices
25–48 of 66
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 Mar 21, 1983
RAICHEM HDL-CHOLESTEROL REAGENT
K830207
Reagents Applications, Inc.
Chemistry · 59d
Cleared Sep 24, 1981
HDL CHOLESTEROL REAGENT
K812574
Pointe Scientific, Inc.,
Chemistry · 15d
Cleared May 14, 1980
HDL REAGENT
K800996
Gilford Diagnostics
Chemistry · 19d
Cleared Dec 07, 1979
CHOL-HDL TEST, HIGH LIPO. CHOL TEST
K792313
Sclavo, Inc.
Chemistry · 21d
Cleared Jun 28, 1979
LANCER HDL SEPARATION KIT
K790865
Sherwood Medical Co.
Chemistry · 52d
Cleared May 03, 1979
H-D-EL
K790372
General Diagnostics
Chemistry · 69d
Cleared Apr 04, 1979
A-GENT-HDL REAGENT
K790329
Abbott Laboratories
Immunology · 47d
Cleared Aug 14, 1978
HDL CENTRIFIKIT
K781093
Beckman Instruments, Inc.
Chemistry · 45d