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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System
510(k) Number K173653
Device Name Alere i Strep A 2, Alere i instrument, Alere i Strep A 2 Control Swab Kit
Applicant
Alere Scarborough, Inc.
10 Southgate Rd.
Scarborough,  ME  04074
Applicant Contact Danielle A. Briggeman
Correspondent
Alere Scarborough, Inc.
10 Southgate Rd.
Scarborough,  ME  04074
Correspondent Contact Danielle A. Briggeman
Regulation Number866.2680
Classification Product Code
PGX  
Subsequent Product Code
OOI  
Date Received11/28/2017
Decision Date 05/02/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Dual Track
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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