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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: 05/24/2024
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Device Name
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Requester
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De Novo
Number
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510(k)
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Decision
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MANDOMETER III AB MANDO DEN070014 K063817 03/31/2011
ID-TAG RESPIRATORY VIRAL PANEL LUMINEX MOLECULAR DIAGNOSTICS, INC. DEN070013 K063765 01/03/2008
MAMMAPRINT AGENDIA BV DEN070009 K062694 02/06/2007
3M N95 HOME RESPIRATOR WITH FLUID RESIST 3M COMPANY DEN060009 K062070 05/08/2007
BINAX NOW MALARIA TEST; MODEL 660-000, 6 INVERNESS MEDICAL PROFESSIONAL DIAGNOSTI DEN070006 K061542 06/13/2007
XPERT EV, MODEL GXEV-100N-10; GENEXPERT CEPHEID DEN070004 K061062 03/16/2007
NEUROSTAR TMS SYSTEM NEURONETICS DEN070003 K061053 10/07/2008
QMT NIMBUS ANTIMICROBIAL BARRIER GAUZE D QUICK-MED TECHNOLOGIES, INC. DEN070002 K060662 02/25/2009
INFLUENZA A/H5 (ASIAN LINEAGE) VIRUS REA CENTERS FOR DISEASE CONTROL AND PREVENTI DEN060008 K060159 02/03/2006
INTROL CF PANEL I CONTROL MAINE MOLECULAR QUALITY CONTROLS, INC. DEN060007 K060070 10/12/2006
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