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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device To Detect And Measure Procalcitonin (Pct) In Human Clinical Specimens
510(k) Number K160911
Device Name VIDAS B.R.A.H.M.S. PCT (PCT)
Applicant
bioMerieux, Inc
595 Anglum Rd.
Hazelwood,  MO  63042
Applicant Contact Thi My Lan Dang
Correspondent
bioMerieux, Inc
595 Anglum Rd.
Hazelwood,  MO  63042
Correspondent Contact Thi My Lan Dang
Regulation Number866.3215
Classification Product Code
PMT  
Date Received04/01/2016
Decision Date 06/28/2016
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
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