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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name kit, identification, enterobacteriaceae
510(k) Number K081309
Device Name E.COLI/P. AERUGINOSA PNA FISH
Applicant
ADVANDX, INC.
10A ROESSLER ROAD
woburn,  MA  01801
Applicant Contact henrik stender
Correspondent
ADVANDX, INC.
10A ROESSLER ROAD
woburn,  MA  01801
Correspondent Contact henrik stender
Regulation Number866.2660
Classification Product Code
JSS  
Date Received05/09/2008
Decision Date 12/19/2008
Decision substantially equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
statement statement
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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