TOXOGEN

Antigens, Iha, Toxoplasma Gondii

INSTRUMENTATION LABORATORY CO.

The following data is part of a premarket notification filed by Instrumentation Laboratory Co. with the FDA for Toxogen.

Pre-market Notification Details

Device IDK981263
510k NumberK981263
Device Name:TOXOGEN
ClassificationAntigens, Iha, Toxoplasma Gondii
Applicant INSTRUMENTATION LABORATORY CO. 180 HARTWELL ROAD Bedford,  MA  01730
ContactCarol Marble
CorrespondentCarol Marble
INSTRUMENTATION LABORATORY CO. 180 HARTWELL ROAD Bedford,  MA  01730
Product CodeGMM  
CFR Regulation Number866.3780 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-04-07
Decision Date1998-08-06
Summary:summary

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