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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name antigens, all types, escherichia coli
510(k) Number K121411
Device Name SHIGA TOXIN CHEK
Applicant
TECHLAB INC., CORPORATE RESEARCH CENTER
2001 KRAFT DR.
BLACKSBURG,  VA  24060 -6358
Applicant Contact DONNA T LINK
Correspondent
TECHLAB INC., CORPORATE RESEARCH CENTER
2001 KRAFT DR.
BLACKSBURG,  VA  24060 -6358
Correspondent Contact DONNA T LINK
Regulation Number866.3255
Classification Product Code
GMZ  
Date Received05/11/2012
Decision Date 10/02/2012
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
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