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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: 04/27/2024
 
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Device Name
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De Novo
Number
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510(k)
Number
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Decision
Date
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Sepax Cell Separation System and Single Biosafe SA BK060036 01/03/2007
TrueGene HIV Genotyping Kit and OpenGene Visible Genetics, Inc. BK000038 06/27/2001
Sentosa SQ HIV Genotyping Assay Vela Diagnostics USA Inc BR190330 11/05/2019
Hemanext ONE Hemanext, Inc. BR220665 09/15/2023
SeCore CDx HLA Sequencing System One Lambda, Inc. BR220737 11/28/2022
OHMEDA INOVENT DELIVERY SYSTEM OHMEDA MEDICAL DEN000001 K974562 01/11/2000
UROSURGE PERCUTANEOUS SANS (STOLLER AFFE UROSURGE, INC. DEN000002 K992069 02/09/2000
QUICKAIR CHOKE RELIEVER, MODEL 59-001A MAET INDUSTRIES, INC. DEN000004 K993284 02/29/2000
EROS-CLITORAL THERAPY DEVICE (CTD) UROMETRICS, INC. DEN000006 K000280 04/28/2000
QUANTA LITE ASCA (S. CEREVISIAE) IGG ELI INOVA DIAGNOSTICS, INC. DEN000007 K000732 08/16/2000
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