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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Herpes Simplex Virus Nucleic Acid Amplification Assay
510(k) Number K150962
Device Name Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control Pack
Applicant
Focus Diagnostics
11331 Valley View St.
Cypress,  CA  90630
Applicant Contact SHARON YOUNG
Correspondent
Focus Diagnostics
11331 Valley View St.
Cypress,  CA  90630
Correspondent Contact SHARON YOUNG
Regulation Number866.3305
Classification Product Code
OQO  
Date Received04/10/2015
Decision Date 08/28/2015
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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