AMEBIASIS BIO-ENZABEAD SCREEN KIT

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

BIONETIC LABORATORY PRODUCTS

The following data is part of a premarket notification filed by Bionetic Laboratory Products with the FDA for Amebiasis Bio-enzabead Screen Kit.

Pre-market Notification Details

Device IDK831133
510k NumberK831133
Device Name:AMEBIASIS BIO-ENZABEAD SCREEN KIT
ClassificationAntigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp.
Applicant BIONETIC LABORATORY PRODUCTS 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeKHW  
CFR Regulation Number866.3220 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1983-04-07
Decision Date1983-06-08

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