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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 K143651
Device Name Simplexa Group A Strep Direct, Simplexa Group A Strep Positive Control Pack
Applicant
Focus Diagnostics, Inc.
11331 Valley View St.
Cypress,  CA  90630
Applicant Contact Sharon Young
Correspondent
Focus Diagnostics, Inc.
11331 Valley View St.
Cypress,  CA  90630
Correspondent Contact Sharon Young
Regulation Number866.2680
Classification Product Code
PGX  
Subsequent Product Code
OOI  
Date Received12/23/2014
Decision Date 03/18/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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