K173653

Substantially Equivalent

Alere i Strep A 2, Alere i instrument, Alere i Strep A 2 Control Swab Kit

Applicant: Alere Scarborough, Inc.
Product code: PGX
Advisory panel: Microbiology
Date received: 2017-11-28
Decision date: 2018-05-02
Decision: Substantially Equivalent
Clearance type: Dual Track
Location: Scarborough, ME, US

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