GENZYME OSOM INFLUENZA A & B TEST

Devices Detecting Influenza A, B, And C Virus Antigens

GENZYME CORP.

The following data is part of a premarket notification filed by Genzyme Corp. with the FDA for Genzyme Osom Influenza A & B Test.

Pre-market Notification Details

Device IDK051244
510k NumberK051244
Device Name:GENZYME OSOM INFLUENZA A & B TEST
ClassificationDevices Detecting Influenza A, B, And C Virus Antigens
Applicant GENZYME CORP. 500 KENDALL STREET Cambridge,  MA  02142
ContactFred D Lasky
CorrespondentFred D Lasky
GENZYME CORP. 500 KENDALL STREET Cambridge,  MA  02142
Product CodePSZ  
CFR Regulation Number866.3328 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-05-16
Decision Date2006-02-21
Summary:summary

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