AMEBIASIS MICROASSAY

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

DIAMEDIX CORP.

The following data is part of a premarket notification filed by Diamedix Corp. with the FDA for Amebiasis Microassay.

Pre-market Notification Details

Device IDK863811
510k NumberK863811
Device Name:AMEBIASIS MICROASSAY
ClassificationAntigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp.
Applicant DIAMEDIX CORP. 2140 NORTH MIAMI AVE. Miami,  FL  33127
ContactLin, Ph.d.
CorrespondentLin, Ph.d.
DIAMEDIX CORP. 2140 NORTH MIAMI AVE. Miami,  FL  33127
Product CodeKHW  
CFR Regulation Number866.3220 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-09-30
Decision Date1986-10-09

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