LPS · Class II · 21 CFR 862.1377

FDA Product Code LPS: Urinary Homocystine (nonquantitative) Test System

Leading manufacturers include Dade Behring, Inc., Diagnostic Products Corp. and Instrumentation Laboratory CO.

29
Total
29
Cleared
109d
Avg days
1998
Since

FDA 510(k) Cleared Urinary Homocystine (nonquantitative) Test System Devices (Product Code LPS)

29 devices
1–24 of 29
Cleared Dec 28, 2006
DIMENSION VISTA HCYS FLEX REAGENT CARTRIDGE
K063206
Dade Behring, Inc.
Chemistry · 66d
Cleared Sep 22, 2006
HEMOSIL HOMOCYSTEINE AND CONTROLS
K061598
Instrumentation Laboratory CO
Chemistry · 106d
Cleared Mar 29, 2006
N LATEX HCY, N PROTEIN STANDARD SL, N/T PROTEIN CONTROL L/M/H
K052788
Dade Behring, Inc.
Chemistry · 177d
Cleared Feb 05, 2001
IMMULITE HOMOCYSTEINE MODEL LKHO1 / IMMULITE 2000 HOMOCYSTEINE MODEL L2KHO2
K003597
Diagnostic Products Corp.
Toxicology · 76d
Cleared Dec 21, 1999
BIO-RAD HOMOCYSTEINE BY HPLC
K993107
Bio-Rad
Toxicology · 95d
Cleared Oct 25, 1999
ABBOTT AXSYM HOMOCYSTEINE
K992858
Abbott Laboratories
Chemistry · 61d

About Product Code LPS - Regulatory Context