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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 K092236
Device Name E.COLI/P. AERUGINOSA PNA FISH
Applicant
Advandx, Inc.
10a Roessler Rd.
Woburn,  MA  01801
Applicant Contact PAULA E BULGER
Correspondent
Advandx, Inc.
10a Roessler Rd.
Woburn,  MA  01801
Correspondent Contact PAULA E BULGER
Regulation Number866.2660
Classification Product Code
JSS  
Date Received07/23/2009
Decision Date 12/16/2009
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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