Cleared Traditional

BGM GALECTIN -3

K093758 · Bg Medicine, Inc. · Chemistry
Nov 2010
Decision
345d
Days
Class 2
Risk

About This 510(k) Submission

K093758 is an FDA 510(k) clearance for the BGM GALECTIN -3, a Galectin-3 In Vitro Diagnostic Assay (Class II — Special Controls, product code OSX), submitted by Bg Medicine, Inc. (Waltham, US). The FDA issued a Cleared decision on November 17, 2010, 345 days after receiving the submission on December 7, 2009. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1117.

Submission Details

510(k) Number K093758 FDA.gov
FDA Decision Cleared SESE
Date Received December 07, 2009
Decision Date November 17, 2010
Days to Decision 345 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code OSX — Galectin-3 In Vitro Diagnostic Assay
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1117
Definition 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.