FUJIREBIO DIAGNOSTICS TUMOR MARKER CONTROL— 510(k) K103676

Substantially Equivalent

Fujirebio Diagnostics,Inc.

FDA 510(k) clearance K103676 for FUJIREBIO DIAGNOSTICS TUMOR MARKER CONTROL, Substantially Equivalent on 2011-07-19. Applicant: Fujirebio Diagnostics,Inc..

Clearance details

Applicant: Fujirebio Diagnostics,Inc.
Product code: Code OIU
Advisory panel: Immunology
Date received: 2010-12-16
Decision date: 2011-07-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Malvern, PA, US

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.