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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Legionella, Spp., Elisa
510(k) Number K934965
Device Name BINAX LEGIONELLA URINARY ANTIGEN EIA
Applicant
Binax, Inc.
217 Read St.
Portland,  ME  04103
Applicant Contact CAROLYN E LAWSON
Correspondent
Binax, Inc.
217 Read St.
Portland,  ME  04103
Correspondent Contact CAROLYN E LAWSON
Regulation Number866.3300
Classification Product Code
MJH  
Date Received10/15/1993
Decision Date 09/20/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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