K173502

Substantially Equivalent

Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza A & B Card 2 Control Swab Kit

Applicant: Alere Scarborough, Inc.
Product code: PSZ
Advisory panel: Microbiology
Date received: 2017-11-13
Decision date: 2017-12-13
Decision: Substantially Equivalent
Clearance type: Special
Location: Scarborough, ME, US

Download summary PDF View on FDA.gov ↗

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