LBR · Class I · 21 CFR 862.1475

FDA Product Code LBR: Ldl & Vldl Precipitation, Hdl

Leading manufacturers include Roche Diagnostic Systems, Inc., Boehringer Mannheim Corp. and Bd Becton Dickinson Vacutainer Systems Preanalytic.

66
Total
66
Cleared
71d
Avg days
1978
Since

FDA 510(k) Cleared Ldl & Vldl Precipitation, Hdl Devices (Product Code LBR)

66 devices
1–24 of 66
Cleared Jan 26, 1998
BOEHRINGER MANNHEIM DIRECT LDL - CHOLESTEROL
K974733
Boehringer Mannheim Corp.
Chemistry · 39d
Cleared Nov 21, 1997
ROCHE UNIMATE HDL DIRECT REAGEN (WITH POL CLAIM)
K973369
Roche Diagnostic Systems, Inc.
Chemistry · 74d
Cleared Jan 09, 1992
IL TEST(TM) HDL CHOLESTEROL
K914811
Instrumentation Laboratory CO
Chemistry · 76d
Cleared Aug 09, 1990
REFLOTRON HDL CHOLESTEROL TEST TABS
K902568
Boehringer Mannheim Corp.
Chemistry · 59d
Cleared Mar 09, 1990
ROCHE SEPARATING REAGENT FOR HDL CHOLESTEROL
K900120
Roche Diagnostic Systems, Inc.
Chemistry · 59d
Cleared Feb 10, 1989
HDL CHOLESTEROL TEST
K885265
Em Diagnostic Systems, Inc.
Chemistry · 50d
Cleared Sep 13, 1988
IQ HDL CHOLESTEROL
K883353
Bd Becton Dickinson Vacutainer Systems Preanalytic
Chemistry · 35d
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

About Product Code LBR - Regulatory Context