LBR · Class I · 21 CFR 862.1475

FDA Product Code LBR: Ldl & Vldl Precipitation, Hdl

Leading manufacturers include Pointe Scientific, Inc.,, Genzyme Corp. and Reference Diagnostics, Inc..

66
Total
66
Cleared
71d
Avg days
1978
Since
66 devices
49–66 of 66
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