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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: 06/01/2024
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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
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EUROIMMUN ANTI-PLA2R IFA EUROIMMUN US DEN140002 K132379 05/29/2014
EEVA 2.0 AUXOGYN, INC. DEN120015 K120427 06/06/2014
REWALK ARGO MEDICAL TECHNOLOGIES, INC. DEN130034 K131798 06/26/2014
STUDIO ON THE CLOUD DATA MANAGEMENT SOFT DEXCOM, INC. DEN140016 08/19/2014
ZINC TRANSPORTER 8 ANTIBODY (ZNT8AB) ELI KRONUS MARKET DEVELOPMENT ASSOCIATES, IN DEN140001 08/20/2014
Medtronic DUET External Drainage and Mon MEDTRONIC NEUROSURGERY DEN120017 08/22/2014
NEPHROCHECK TEST SYSTEM ASTUTE MEDICAL, INC DEN130031 09/05/2014
T2CANDIDA AND T2DX INSTRUMENT T2 BIOSYSTEMS, INC DEN140019 09/22/2014
INFLOW INTRAURETHRAL VALVE-PUMP VESIFLO, INC. DEN130044 10/14/2014
ZAP-IT! ECOBRANDS LTD. DEN100024 11/07/2014
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