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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: 05/31/2024
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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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WALLAC NEONATAL BIOTINIDASE TEST KIT, MO WALLAC, INC. DEN990008 K992284 02/15/2000
PERKINELMER ENLITE NEONATAL TREC TEST SY WALLAC OY DEN140010 12/15/2014
LBA AFP-L3, AFP-L3 CALIBRATOR SET, AFP-L WAKO CHEMICALS, USA, INC. DEN050002 K041847 05/19/2005
VYSIS AUTOVYSION SYSTEM VYSIS DEN040010 K041875 12/13/2004
ContaCT Viz.Al, Inc. DEN170073 02/13/2018
Viz HCM Viz.ai, Inc. DEN230003 08/03/2023
TrueGene HIV Genotyping Kit and OpenGene Visible Genetics, Inc. BK000038 06/27/2001
VIRULITE COLD SORE MACHINE VIRULITE LLC DEN090012 K083767 10/18/2012
MIRA Surgical System Virtual Incision DEN230025 02/23/2024
vPatch Virility Medical DEN210012 11/23/2021
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