K123355

Substantially Equivalent

AMPLIVUE C. DIFFICILE ASSAY

Applicant: Quidel Corporation
Product code: OZN
Advisory panel: Microbiology
Date received: 2012-10-31
Decision date: 2012-12-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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