TREND AMEBIASIS (E.HISTOLYTICA) SEROLOGICAL ELISA TEST SYSTEM

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

TREND SCIENTIFIC, INC.

The following data is part of a premarket notification filed by Trend Scientific, Inc. with the FDA for Trend Amebiasis (e.histolytica) Serological Elisa Test System.

Pre-market Notification Details

Device IDK954996
510k NumberK954996
Device Name:TREND AMEBIASIS (E.HISTOLYTICA) SEROLOGICAL ELISA TEST SYSTEM
ClassificationAntigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp.
Applicant TREND SCIENTIFIC, INC. 368 WEST COUNTY RD. D New Brighton,  MN  55112
ContactMariellyn Truax
CorrespondentMariellyn Truax
TREND SCIENTIFIC, INC. 368 WEST COUNTY RD. D New Brighton,  MN  55112
Product CodeKHW  
CFR Regulation Number866.3220 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-11-01
Decision Date1996-08-08
Summary:summary

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