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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Real Time Nucleic Acid Amplification System
510(k) Number K151690
Device Name Alere i Instrument, Alere i Influenza A & B, Alere i Strep A
Applicant
Alere Scarborough, Inc.
10 Southgate Rd.,
Scarborough,  ME  04074
Applicant Contact Angela Drysdale
Correspondent
Alere Scarborough, Inc.
10 Southgate Rd.,
Scarborough,  ME  04074
Correspondent Contact Angela Drysdale
Regulation Number862.2570
Classification Product Code
OOI  
Subsequent Product Codes
OCC   OZE   PGX  
Date Received06/23/2015
Decision Date 07/16/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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