BINAX LEGIONELLA URINARY ANTIGEN EIA

Legionella, Spp., Elisa

BINAX, INC.

The following data is part of a premarket notification filed by Binax, Inc. with the FDA for Binax Legionella Urinary Antigen Eia.

Pre-market Notification Details

Device IDK934965
510k NumberK934965
Device Name:BINAX LEGIONELLA URINARY ANTIGEN EIA
ClassificationLegionella, Spp., Elisa
Applicant BINAX, INC. 217 READ ST. Portland,  ME  04103
ContactCarolyn E Lawson
CorrespondentCarolyn E Lawson
BINAX, INC. 217 READ ST. Portland,  ME  04103
Product CodeMJH  
CFR Regulation Number866.3300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-10-15
Decision Date1994-09-20

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10811877010767 K934965 000
10811877010460 K934965 000

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