ARCHITECT CYCLOSPORINE— 510(k) K080751

Substantially Equivalent

Fujirebio Diagnostics,Inc.

FDA 510(k) clearance K080751 for ARCHITECT CYCLOSPORINE, Substantially Equivalent on 2008-09-11. Applicant: Fujirebio Diagnostics,Inc..

Clearance details

Applicant: Fujirebio Diagnostics,Inc.
Product code: Code MKW
Advisory panel: Clinical Chemistry
Date received: 2008-03-18
Decision date: 2008-09-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Malvern, PA, US

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