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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 K121364
Device Name SHIGA TOXIN QUIK 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 Received05/07/2012
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
Predetermined Change
Control Plan Authorized		 No
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