LBT · Class I · 21 CFR 862.1475

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

Leading manufacturers include Helena Laboratories, Roche Diagnostics Corp. and Gelman Sciences, Inc..

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 Oct 27, 1997
HYDRAGEL 7,15,30, CHOL-HDL KIT
K972015
Morax
Chemistry · 150d
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
Cleared Jun 15, 1979
ELECTROPHORESIS REAGENT SET, HDL
K790791
Gelman Sciences, Inc.
Chemistry · 52d

About Product Code LBT - Regulatory Context