OSX · Class II · 21 CFR 862.1117

FDA Product Code OSX: Galectin-3 In Vitro Diagnostic Assay

Galectin-3 Is Indicated For Use In Conjunction With Clinical Evaluation As An Aid In Assessing The Prognosis Of Patients Diagnosed With Chronic Heart Failure.

Leading manufacturers include Bg Medicine, Inc. and Fujirebio Diagnostics,Inc..

2
Total
2
Cleared
325d
Avg days
2010
Since

FDA 510(k) Cleared Galectin-3 In Vitro Diagnostic Assay Devices (Product Code OSX)

2 devices
1–2 of 2
Cleared Dec 23, 2014
ARCHITECT GALECTIN-3 Reagent Kit, ARCHITECT GALECTIN-3 CALIBRATORS, ARCHITECT GALECTIN-3 CONTROLS
K140436
Fujirebio Diagnostics,Inc.
Chemistry · 305d
Cleared Nov 17, 2010
BGM GALECTIN -3
K093758
Bg Medicine, Inc.
Chemistry · 345d

About Product Code OSX - Regulatory Context