ENTAMOEBA TEST

Antigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp.

TECHLAB, INC.

The following data is part of a premarket notification filed by Techlab, Inc. with the FDA for Entamoeba Test.

Pre-market Notification Details

Device IDK944791
510k NumberK944791
Device Name:ENTAMOEBA TEST
ClassificationAntigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp.
Applicant TECHLAB, INC. 1861 PRATT DR. CORPORATE RESEARCH CENTER Blacksburg,  VA  24060 -6364
ContactPatricia Shrader
CorrespondentPatricia Shrader
TECHLAB, INC. 1861 PRATT DR. CORPORATE RESEARCH CENTER Blacksburg,  VA  24060 -6364
Product CodeKHW  
CFR Regulation Number866.3220 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-09-28
Decision Date1995-03-09

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