K162642

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: 2016-09-22
Decision date: 2017-04-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Scarborough, ME, US

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