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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 K944791
Device Name ENTAMOEBA TEST
Applicant
Techlab, Inc.
1861 Pratt Dr.
Corporate Research Center
Blacksburg,  VA  24060
Applicant Contact PATRICIA SHRADER
Correspondent
Techlab, Inc.
1861 Pratt Dr.
Corporate Research Center
Blacksburg,  VA  24060
Correspondent Contact PATRICIA SHRADER
Regulation Number866.3220
Classification Product Code
KHW  
Date Received09/28/1994
Decision Date 03/09/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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