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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Respiratory Virus Panel Nucleic Acid Assay System
510(k) Number K152408
Device Name Simplexa Flu A/B & RSV Direct and Simplexa Flu A/B & RSV Positive Control Pack
Applicant
Focus Diagnostics, Inc.
11331 Valley View St.
Cypress,  CA  90630
Applicant Contact IRENE M GUZMAN
Correspondent
Focus Diagnostics, Inc.
11331 Valley View St.
Cypress,  CA  90630
Correspondent Contact IRENE M GUZMAN
Regulation Number866.3980
Classification Product Code
OCC  
Date Received08/25/2015
Decision Date 09/21/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
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
Recalls CDRH Recalls
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