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
