Name: Predicase
Price: 199 USD

K-number	K140436
Device name	ARCHITECT GALECTIN-3 Reagent Kit, ARCHITECT GALECTIN-3 CALIBRATORS, ARCHITECT GALECTIN-3 CONTROLS
Applicant	Fujirebio Diagnostics,Inc.
Product code	OSX
Device class	Class II
Decision date	Dec 23, 2014
Decision	Substantially Equivalent
Regulation	862.1117

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Source

View the full FDA submission: accessdata.fda.gov

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

Everything you need for a 510(k) submission. Nothing you don't.