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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 K030991
Device Name C. DIFF CHEK - 30
Applicant
Techlab, Inc.
1861 Pratt Dr., Suite 1030
Blacksburg,  VA  24060
Applicant Contact DAVID M LYERLY
Correspondent
Techlab, Inc.
1861 Pratt Dr., Suite 1030
Blacksburg,  VA  24060
Correspondent Contact DAVID M LYERLY
Regulation Number866.2660
Classification Product Code
LLH  
Date Received03/28/2003
Decision Date 07/11/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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