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FDA 510(k) K141757, ALERE I STREP A, by Alere Scarborough, Inc.

FDA 510(k) K141757, ALERE I STREP A, by Alere Scarborough, Inc.

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510(K) Number: K141757
Device Name: ALERE I STREP A
Manufacturer: Alere Scarborough, Inc.
Device Classification Name: Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System
Regulation Number: PGX
Classification Product Code: KXA
Date Received: 06/30/2014
Decision Date: 03/31/2015
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Microbiology
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