ARCHITECT CA 125 II ASSAY— 510(k) K042731

Substantially Equivalent

Fujirebio Diagnostics,Inc.

FDA 510(k) clearance K042731 for ARCHITECT CA 125 II ASSAY, Substantially Equivalent on 2004-11-19. Applicant: Fujirebio Diagnostics,Inc..

Clearance details

Applicant: Fujirebio Diagnostics,Inc.
Product code: Code LTK
Advisory panel: Immunology
Date received: 2004-10-01
Decision date: 2004-11-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Malvern, PA, US

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