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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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De Novo
Number
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510(k)
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Decision
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DULBECCO'S MODIFIED EAGLE MEDIUM (DMEM) LIFE TECHNOLOGIES, INC. DEN000008 K001447 02/16/2001
TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) BIOSITE INCORPORATED DEN000010 K003475 11/20/2000
GIVEN DIAGNOSTIC IMAGING SYSTEM GIVEN IMAGING LTD. DEN010002 K010312 08/01/2001
BREASTVIEW VISUAL MAPPING SYSTEM ASSURANCE MEDICAL DEN020001 K010514 01/31/2003
RETROX AURIC HEARING SYSTEMS, INC. DEN020003 K013298 08/20/2002
NIOX ARTICLE NO: 02-1000 AEROCRINE AB DEN030001 K021133 04/30/2003
ENDOTOXIN ACTIVITY ASSAY (EAA) DEVICE SPECTRAL DIAGNOSTICS, INC. DEN030002 K021885 06/16/2003
WEST NILE VIRUS IGM CAPTURE ELISA PANBIO LIMITED DEN030004 K031703 07/08/2003
FACTOR V LEIDEN KIT ROCHE DIAGNOSTICS CORP. DEN030005 K033607 12/17/2003
CELLSEARCH EPITHELIAL CELL ENRICHMENT KI ADVANCED DIAGNOSTIC SYSTEMS DEN040001 K031588 01/21/2004
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