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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 K003306
Device Name C. DIFFICILE TOX A/B II
Applicant
Techlab, Inc.
Vpi Research Park
1861 Pratt Dr.
Blacksburg,  VA  24060
Applicant Contact DAVID M LYERLY
Correspondent
Techlab, Inc.
Vpi Research Park
1861 Pratt Dr.
Blacksburg,  VA  24060
Correspondent Contact DAVID M LYERLY
Regulation Number866.2660
Classification Product Code
LLH  
Date Received10/20/2000
Decision Date 11/22/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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