K093116

Substantially Equivalent

MODIFICATION TO: RAMP INFLUENZA A/B ASSAY

Applicant: Response Biomedical Corp.
Product code: PSZ
Advisory panel: Microbiology
Date received: 2009-10-02
Decision date: 2009-10-21
Decision: Substantially Equivalent
Clearance type: Special
Location: Vancouver, B.C, CA

Download summary PDF View on FDA.gov ↗

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