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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antigen, Inflammatory Response Marker, Sepsis
510(k) Number K071146
Device Name VIDAS B.R.A.H.M.S. PCT ASSAY
Applicant
BIOMERIEUX, INC.
595 ANGLUM RD.
HAZELWOOD,  MO  63042
Applicant Contact NIKITA S MAPP
Correspondent
BIOMERIEUX, INC.
595 ANGLUM RD.
HAZELWOOD,  MO  63042
Correspondent Contact NIKITA S MAPP
Regulation Number866.3210
Classification Product Code
NTM  
Date Received04/24/2007
Decision Date 10/11/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
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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