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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 K070522
Device Name MODIFICATION TO: BINAX NOW LEGIONELLA URINARY ANTIGEN TEST, #852-000,852-012
Applicant
Inverness Medical Professional Diagnostics
10 Southgate Rd.,
Scarborough,  ME  04074
Applicant Contact KAREN MORTIMER
Correspondent
Inverness Medical Professional Diagnostics
10 Southgate Rd.,
Scarborough,  ME  04074
Correspondent Contact KAREN MORTIMER
Regulation Number866.3300
Classification Product Code
MJH  
Date Received02/23/2007
Decision Date 03/15/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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