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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: 06/14/2024
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Download Files | More About De Novo
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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IMMUNOCAP TRYPTASE, CALIBRATORS, CURVE C PHADIA US INC. DEN120001 K103039 02/15/2012
STRATIFY JCV(TM) ANTIBODY FOCUS DIAGNOSTICS, INC. DEN120008 K112394 01/20/2012
PROTEUS INGESTION CONFINMATION SYSTEMS PROTEUS BIOMEDICAL, INC. DEN120011 K113070 07/10/2012
CDC DENV-1-4 REAL TIME RT-PCT ASSAY CENTERS FOR DISEASE CONTROL AND PREVENTI DEN120012 K113336 05/24/2012
PORTRAIT ANALYZER GREAT BASIN SCIENTIFIC DEN120013 K113358 04/30/2012
VERIGENE GRAM POSITIVE BLOOD CULTURE NUC NANOSPHERE, INC DEN120014 K113450 06/26/2012
EEVA 2.0 AUXOGYN, INC. DEN120015 K120427 06/06/2014
DEKA ARM SYSTEM DEKA INTEGRATED SOLUTIONS CORPORATION DEN120016 K121215 05/09/2014
Medtronic DUET External Drainage and Mon MEDTRONIC NEUROSURGERY DEN120017 08/22/2014
CEFALY STX-MED SPRL DEN120019 K122566 03/11/2014
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