ARCHITECT CA 15-3 ASSAY— 510(k) K042732

Substantially Equivalent

Fujirebio Diagnostics,Inc.

FDA 510(k) clearance K042732 for ARCHITECT CA 15-3 ASSAY, Substantially Equivalent on 2004-12-22. Applicant: Fujirebio Diagnostics,Inc..

Clearance details

Applicant: Fujirebio Diagnostics,Inc.
Product code: Code MOI
Advisory panel: Immunology
Date received: 2004-10-01
Decision date: 2004-12-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Malvern, PA, US

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