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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 K021486
Device Name HERPESELECT 2 ELISA IGG, MODEL ELO920G
Applicant
Focus Technologies, Inc.
10703 Progress Way
Cypress,  CA  90630
Applicant Contact MICHAEL J WAGNER
Correspondent
Focus Technologies, Inc.
10703 Progress Way
Cypress,  CA  90630
Correspondent Contact MICHAEL J WAGNER
Regulation Number866.3305
Classification Product Code
MXJ  
Date Received05/03/2002
Decision Date 08/01/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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