K182001

Substantially Equivalent

Acucy Influenza A&B Test with the Acucy System

Applicant: SEKISUI Diagnostics, LLC
Product code: PSZ
Advisory panel: Microbiology
Date received: 2018-07-26
Decision date: 2018-12-17
Decision: Substantially Equivalent
Clearance type: Dual Track
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.