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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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11 to 20 of 415 results
Decision Date To: 05/24/2024
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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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QUIDEL MOLECULAR DIRECT HSV 1 +2/VZV ASS DIAGNOSTIC HYBRIDS, INC. DEN140004 K133448 05/13/2014
MISEQDX UNIVERSAL KIT 1.0 ILLUMINA, INC. DEN130042 K133136 11/19/2013
IOGYN SYSTEM IOGYN, INC. DEN130040 K132695 03/28/2014
EUROIMMUN ANTI-PLA2R IFA EUROIMMUN US DEN140002 K132379 05/29/2014
PROSTATE IMMOBILIZER RECTAL BALLOON RADIADYNE DEN130036 K132194 01/28/2014
REWALK ARGO MEDICAL TECHNOLOGIES, INC. DEN130034 K131798 06/26/2014
XPERT MTB/RIF ASSAY CEPHEID DEN130032 K131706 07/25/2013
UROLIFT SYSTEM NEOTRACT, INC. DEN130023 K130651 09/13/2013
NEURALIEVE CERENA TRANSCRANIAL MAGNETIC ENEURA THERAPEUTICS DEN130022 K130556 12/13/2013
CYTOSCAN(R) DX Affymetrix, Inc. DEN130018 K130313 01/17/2014
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