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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, mass spectrometry, maldi tof, microorganism identification, cultured isolates
510(k) Number K162950
Device Name VITEK MS
Applicant
bioMerieux, Inc.
595 Anglum Rd.
Hazelwood,  MO  63042
Applicant Contact Nathan Hardesty
Correspondent
bioMerieux, Inc.
595 Anglum Rd.
Hazelwood,  MO  63042
Correspondent Contact Nathan Hardesty
Regulation Number866.3361
Classification Product Code
PEX  
Date Received10/24/2016
Decision Date 07/22/2017
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
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