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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Giardia Spp.
510(k) Number K033274
Device Name GIARDIA II
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 Number866.3220
Classification Product Code
MHI  
Date Received10/10/2003
Decision Date 11/04/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Statement Statement
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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