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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 K062543
Device Name HERPESELECT 1 AND 2 PLEXUS IGG, MODEL MP0900G
Applicant
Focus Diagnostics, Inc.
10703 Progress Way
Cypress,  CA  90630
Applicant Contact MICHEAL J WAGNER,ESQ.
Correspondent
Focus Diagnostics, Inc.
10703 Progress Way
Cypress,  CA  90630
Correspondent Contact MICHEAL J WAGNER,ESQ.
Regulation Number866.3305
Classification Product Code
MXJ  
Subsequent Product Code
MYF  
Date Received08/30/2006
Decision Date 02/01/2007
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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