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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 K042071
Device Name IBD-SCAN
Applicant
TECHLAB, INC.
2001 KRAFT DR.
BLACKSBURG,  VA  24060 -6358
Applicant Contact DAVID M LYERLY
Correspondent
TECHLAB, INC.
2001 KRAFT DR.
BLACKSBURG,  VA  24060 -6358
Correspondent Contact DAVID M LYERLY
Regulation Number866.5570
Classification Product Code
DEG  
Date Received08/02/2004
Decision Date 10/20/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Statement Statement
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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