510(k) K173502— Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza A & B Card 2 Control Swab Kit

Substantially Equivalent

Alere Scarborough, Inc.

Clearance details

Applicant: Alere Scarborough, Inc.
Product code: 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

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