DeviceClearance

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

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..

Clearance details

Applicant
Fujirebio Diagnostics,Inc.
Product code
Code OSX
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Malvern, PA, US
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