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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: 05/15/2024
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Download Files | More About De Novo
Device Name
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De Novo
Number
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510(k)
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Decision
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COMPUTERIZED LABOR MONITORING SYSTEM BARNEV, LTD. DEN060006 K060028 01/30/2007
MAMMAPRINT AGENDIA BV DEN070009 K062694 02/06/2007
TEPHAFLEX ABSORBABLE SUTURE TEPHA, INC. DEN060003 K052225 02/08/2007
XPERT EV, MODEL GXEV-100N-10; GENEXPERT CEPHEID DEN070004 K061062 03/16/2007
3M N95 HOME RESPIRATOR WITH FLUID RESIST 3M COMPANY DEN060009 K062070 05/08/2007
INRANGE REMOTE MEDICATION MANAGEMENT SYS INRANGE SYSTEMS, INC. DEN060002 K051338 06/13/2007
BINAX NOW MALARIA TEST; MODEL 660-000, 6 INVERNESS MEDICAL PROFESSIONAL DIAGNOSTI DEN070006 K061542 06/13/2007
ID-TAG RESPIRATORY VIRAL PANEL LUMINEX MOLECULAR DIAGNOSTICS, INC. DEN070013 K063765 01/03/2008
ALLOMAP MOLECULAR EXPRESSION TESTING XDX DEN080007 K073482 08/26/2008
NEUROSTAR TMS SYSTEM NEURONETICS DEN070003 K061053 10/07/2008
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