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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1
510(k) Number K071510
Device Name HERPESELECT EXPRESS IGG, HERPESELECT EXPRESS CONTROLS, MODELS RT0920G, RT0950
Applicant
Focus Diagnostics, Inc.
10703 Progress Way
Cypress,  CA  90630
Applicant Contact CONSTANCE BRIDGES
Correspondent
Focus Diagnostics, Inc.
10703 Progress Way
Cypress,  CA  90630
Correspondent Contact CONSTANCE BRIDGES
Regulation Number866.3305
Classification Product Code
MXJ  
Date Received06/04/2007
Decision Date 09/24/2007
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
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