ALERE I STREP A— 510(k) K141757

Substantially Equivalent

Alere Scarborough, Inc.

FDA 510(k) clearance K141757 for ALERE I STREP A, Substantially Equivalent on 2015-03-31. Applicant: Alere Scarborough, Inc..

Clearance details

Applicant: Alere Scarborough, Inc.
Product code: Code PGX
Advisory panel: Microbiology
Date received: 2014-06-30
Decision date: 2015-03-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Scarborough, ME, US

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