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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp.
510(k) Number K994101
Device Name E. HISTOLYTICA 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
KHW  
Date Received12/06/1999
Decision Date 12/21/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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