DeviceClearance

Alere BinaxNOW Influenza A & B Card 2, Alere Reader— 510(k) K181853

Substantially Equivalent

Alere Scarborough, Inc.

FDA 510(k) clearance K181853 for Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Substantially Equivalent on 2018-08-08. Applicant: Alere Scarborough, Inc..

Clearance details

Applicant
Alere Scarborough, Inc.
Product code
Code PSZ
Advisory panel
Microbiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Scarborough, ME, US
Download summary PDFView on FDA.gov ↗

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