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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 K030704
Device Name IBD-QUIK CHEK
Applicant
Techlab, Inc.
1861 Pratt Dr., Suite 1030
Blacksburg,  VA  24060 -6364
Applicant Contact DAVID M LYERLY
Correspondent
Techlab, Inc.
1861 Pratt Dr., Suite 1030
Blacksburg,  VA  24060 -6364
Correspondent Contact DAVID M LYERLY
Regulation Number866.5570
Classification Product Code
DEG  
Date Received03/06/2003
Decision Date 04/21/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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