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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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Decision Date To: 05/11/2024
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Device Name
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Requester
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De Novo
Number
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510(k)
Number
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Decision
Date
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INFLUENZA A/H5 (ASIAN LINEAGE) VIRUS REA CENTERS FOR DISEASE CONTROL AND PREVENTI DEN060008 K060159 02/03/2006
3M N95 HOME RESPIRATOR WITH FLUID RESIST 3M COMPANY DEN060009 K062070 05/08/2007
NON-VARIOLA ORTHOPOXVIRUS REAL-TIME PCR CENTERS FOR DISEASE CONTROL AND PREVENTI DEN070001 09/21/2018
QMT NIMBUS ANTIMICROBIAL BARRIER GAUZE D QUICK-MED TECHNOLOGIES, INC. DEN070002 K060662 02/25/2009
NEUROSTAR TMS SYSTEM NEURONETICS DEN070003 K061053 10/07/2008
XPERT EV, MODEL GXEV-100N-10; GENEXPERT CEPHEID DEN070004 K061062 03/16/2007
BINAX NOW MALARIA TEST; MODEL 660-000, 6 INVERNESS MEDICAL PROFESSIONAL DIAGNOSTI DEN070006 K061542 06/13/2007
MAMMAPRINT AGENDIA BV DEN070009 K062694 02/06/2007
ID-TAG RESPIRATORY VIRAL PANEL LUMINEX MOLECULAR DIAGNOSTICS, INC. DEN070013 K063765 01/03/2008
MANDOMETER III AB MANDO DEN070014 K063817 03/31/2011
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