ARCHITECT GALECTIN-3 Reagent Kit, ARCHITECT GALECTIN-3 CALIBRATORS, ARCHITECT GALECTIN-3 CONTROLS— 510(k) K140436

Name: FDA 510(k) clearance K140436
Creator: U.S. Food and Drug Administration
Published: 2014-12-23

Substantially Equivalent

Fujirebio Diagnostics,Inc.

FDA 510(k) clearance K140436 for ARCHITECT GALECTIN-3 Reagent Kit, ARCHITECT GALECTIN-3 CALIBRATORS, ARCHITECT GALECTIN-3 CONTROLS, Substantially Equivalent on 2014-12-23. Applicant: Fujirebio Diagnostics,Inc.. Device class: 2.

Clearance details

Applicant: Fujirebio Diagnostics,Inc.
Product code: Code OSX
Device class: Class 2
Regulation: 21 CFR 862.1117
Advisory panel: Clinical Chemistry
Date received: 2014-02-21
Decision date: 2014-12-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Malvern, PA, US

Download summary PDF View on FDA.gov ↗

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