OSOM C. DIFFICILE TOXIN A/B TEST

Reagents, Clostridium Difficile Toxin

GENZYME CORPORATION

The following data is part of a premarket notification filed by Genzyme Corporation with the FDA for Osom C. Difficile Toxin A/b Test.

Pre-market Notification Details

Device IDK102242
510k NumberK102242
Device Name:OSOM C. DIFFICILE TOXIN A/B TEST
ClassificationReagents, Clostridium Difficile Toxin
Applicant GENZYME CORPORATION 31 NEW YORK AVENUE Framingham,  MA  01701
ContactCarol C Ryerson
CorrespondentCarol C Ryerson
GENZYME CORPORATION 31 NEW YORK AVENUE Framingham,  MA  01701
Product CodeLLH  
CFR Regulation Number866.2660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-08-09
Decision Date2010-12-21
Summary:summary

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