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U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)

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Device Classification Name system, mass spectrometry, maldi tof, microorganism identification, cultured isolates
De Novo Number DEN130013
510(K) Number K124067
Device Name VITEK MS
595 anglum rd.
hazelwood,  MO  63042
Contact nancy weaver
Regulation Number866.3361
Classification Product Code
Date Received01/02/2013
Decision Date 08/21/2013
Decision granted (DENG)
Classification Advisory Committee Microbiology
Review Advisory Committee Microbiology
Reclassification Order Reclassification Order
FDA Review Decision Summary
Type Direct