ID NOW Influenza A & B 2— 510(k) K190204

Substantially Equivalent

Alere Scarborough, Inc.

FDA 510(k) clearance K190204 for ID NOW Influenza A & B 2, Substantially Equivalent on 2019-03-18. Applicant: Alere Scarborough, Inc..

Clearance details

Applicant: Alere Scarborough, Inc.
Product code: Code OZE
Advisory panel: Microbiology
Date received: 2019-02-04
Decision date: 2019-03-18
Decision: Substantially Equivalent
Clearance type: Special
Location: Scarborough, ME, US

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