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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 K955895
Device Name E. HISTOLYTICA TEST
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 Received12/26/1995
Decision Date 08/30/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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