HEM AVE-TOXO TITRATION HEMAGGLUTINATION TEST KIT

Antigens, Iha, Toxoplasma Gondii

SI SERO-IMMUNO DIAGNOSTICS, INC.

The following data is part of a premarket notification filed by Si Sero-immuno Diagnostics, Inc. with the FDA for Hem Ave-toxo Titration Hemagglutination Test Kit.

Pre-market Notification Details

Device IDK851977
510k NumberK851977
Device Name:HEM AVE-TOXO TITRATION HEMAGGLUTINATION TEST KIT
ClassificationAntigens, Iha, Toxoplasma Gondii
Applicant SI SERO-IMMUNO DIAGNOSTICS, INC. P.O. BOX 1230 Tucker,  GA  30085
ContactIrving G Kagan
CorrespondentIrving G Kagan
SI SERO-IMMUNO DIAGNOSTICS, INC. P.O. BOX 1230 Tucker,  GA  30085
Product CodeGMM  
CFR Regulation Number866.3780 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-05-07
Decision Date1985-10-16

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