BINAXNOW INFLUENZA A & B TEST

Devices Detecting Influenza A, B, And C Virus Antigens

BINAX, INC.

The following data is part of a premarket notification filed by Binax, Inc. with the FDA for Binaxnow Influenza A & B Test.

Pre-market Notification Details

Device IDK062109
510k NumberK062109
Device Name:BINAXNOW INFLUENZA A & B TEST
ClassificationDevices Detecting Influenza A, B, And C Virus Antigens
Applicant BINAX, INC. 10 SOUTHGATE RD. Scarborough,  ME  04074
ContactAngela Drysdale
CorrespondentAngela Drysdale
BINAX, INC. 10 SOUTHGATE RD. Scarborough,  ME  04074
Product CodePSZ  
CFR Regulation Number866.3328 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-07-24
Decision Date2006-11-09
Summary:summary

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