LPS · Class II · 21 CFR 862.1377

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

Leading manufacturers include Diazyme Laboratories, Axis-Shield Diagnostics, Ltd. and Axis Biochemicals, Asa.

29
Total
29
Cleared
109d
Avg days
1998
Since
29 devices
25–29 of 29
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
Cleared Oct 06, 1999
MODIFICATION TO IMX HOMOCYSTEINE
K992274
Axis Biochemicals, Asa
Chemistry · 92d
Cleared Feb 11, 1999
DS30 HCY HOMOCYSTEINE ASSAY KIT
K982003
Drew Scientific , Ltd.
Hematology · 248d
Cleared Oct 16, 1998
AXIS HOMOCYSTEINE ENZYME IMMUNOASSAY
K980907
Axis Biochemicals, Asa
Chemistry · 220d