BINAX NOW FLU A TEST (27 TEST), BINAX NOW NASOPHARYNGEAL SWAB SPECIMEN ACCESORY PACK

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 Binax Now Flu A Test (27 Test), Binax Now Nasopharyngeal Swab Specimen Accesory Pack.

Pre-market Notification Details

Device IDK021649
510k NumberK021649
Device Name:BINAX NOW FLU A TEST (27 TEST), BINAX NOW NASOPHARYNGEAL SWAB SPECIMEN ACCESORY PACK
ClassificationDevices Detecting Influenza A, B, And C Virus Antigens
Applicant BINAX, INC. 217 READ ST. Portland,  ME  04103
ContactAnne Jepson
CorrespondentAnne Jepson
BINAX, INC. 217 READ ST. Portland,  ME  04103
Product CodePSZ  
CFR Regulation Number866.3328 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-05-20
Decision Date2002-09-19
Summary:summary

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