PDQ AMEBIASIS

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 Pdq Amebiasis.

Pre-market Notification Details

Device IDK862473
510k NumberK862473
Device Name:PDQ AMEBIASIS
ClassificationAntigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp.
Applicant DIAMEDIX CORP. 2140 NORTH MIAMI AVE. Miami,  FL  33127
ContactTsue-ming Lin
CorrespondentTsue-ming Lin
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 Received1986-06-30
Decision Date1986-08-01

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