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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
Model T30696
Device Name SHIGA TOXIN CHEK
Original Applicant
TECHLAB INC., CORPORATE RESEARCH CENTER
2001 kraft dr.
blacksburg,  VA  24060 6358
Original Contact donna t link
Regulation Number866.3255
Classification Product Code
GMZ  
Date Received05/11/2012
Decision Date 10/02/2012
Decision substantially equivalent - CLIA submission (CS)
Classification Advisory Committee Microbiology
Review Advisory Committee Microbiology
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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