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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Reagents, Clostridium Difficile Toxin
510(k) Number K082499
Device Name C. DIFF QUIK CHEK COMPLETE
Applicant
Techlab, Inc.
2001 Kraft Dr.
Blacksburg,  VA  24060 -6358
Applicant Contact CHARLES PENNINGTON
Correspondent
Techlab, Inc.
2001 Kraft Dr.
Blacksburg,  VA  24060 -6358
Correspondent Contact CHARLES PENNINGTON
Regulation Number866.2660
Classification Product Code
LLH  
Date Received08/29/2008
Decision Date 03/26/2009
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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