LBT · Class I · 21 CFR 862.1475

FDA Product Code LBT: Electrophoresis, Cholesterol Via Esterase-oxidase, Hdl

Leading manufacturers include Helena Laboratories and Roche Diagnostics Corp..

8
Total
8
Cleared
90d
Avg days
1979
Since

FDA 510(k) Cleared Electrophoresis, Cholesterol Via Esterase-oxidase, Hdl Devices (Product Code LBT)

8 devices
1–8 of 8
Cleared Aug 04, 2000
HDL CHOLESTEROL PLUS
K000568
Roche Diagnostics Corp.
Chemistry · 164d
Cleared Nov 09, 1990
REP ULTRA HDL,VLDL/LDL CHOLESTEROL SYSTEM
K904035
Helena Laboratories
Chemistry · 70d
Cleared Aug 31, 1989
REP HDL-8 KIT, NO. 3188, REP HDL-16 KIT, NO. 3187
K894366
Helena Laboratories
Chemistry · 48d
Cleared Aug 08, 1988
REP HDL ELECTROPHORESIS METHOD
K882368
Helena Laboratories
Chemistry · 61d
Cleared Oct 02, 1987
TITAN GEL HDL CHOLESTEROL KIT
K873547
Helena Laboratories
Chemistry · 31d

About Product Code LBT - Regulatory Context