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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lactoferrin, Antigen, Antiserum, Control
510(k) Number K071712
Device Name LEUKO EZ VUE
Applicant
Techlab Inc., Corporate Research Center
2001 Kraft Dr.
Blacksburg,  VA  24060
Applicant Contact CHARLES PENNINGTON
Correspondent
Techlab Inc., Corporate Research Center
2001 Kraft Dr.
Blacksburg,  VA  24060
Correspondent Contact CHARLES PENNINGTON
Regulation Number866.5570
Classification Product Code
DEG  
Date Received06/22/2007
Decision Date 12/04/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
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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