Cleared Traditional

ARCHITECT GALECTIN-3 Reagent Kit, ARCHITECT GALECTIN-3 CALIBRATORS, ARCHITECT GALECTIN-3 CONTROLS

K140436 · Fujirebio Diagnostics,Inc. · Chemistry
Dec 2014
Decision
305d
Days
Class 2
Risk

About This 510(k) Submission

K140436 is an FDA 510(k) clearance for the ARCHITECT GALECTIN-3 Reagent Kit, ARCHITECT GALECTIN-3 CALIBRATORS, ARCHITECT GALECTIN-3 CONTROLS, a Galectin-3 In Vitro Diagnostic Assay (Class II — Special Controls, product code OSX), submitted by Fujirebio Diagnostics,Inc. (Malvern, US). The FDA issued a Cleared decision on December 23, 2014, 305 days after receiving the submission on February 21, 2014. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1117.

Submission Details

510(k) Number K140436 FDA.gov
FDA Decision Cleared SESE
Date Received February 21, 2014
Decision Date December 23, 2014
Days to Decision 305 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.