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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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81 to 90 of 413 results
Decision Date To: 05/17/2024
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Device Name
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Requester
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De Novo
Number
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510(k)
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Decision
Date
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esolution S4 Medical Corp DEN230006 09/06/2023
Ruthless Spine RJB Ruthless, LLC dba Ruthless Spine DEN230012 07/14/2023
AccuMeasure System RQMIS Inc. DEN210032 07/26/2022
AMPLICHIP CYP450 TEST, MODEL 04381866190 ROCHE MOLECULAR SYSTEMS, INC. DEN040011 K042259 12/23/2004
cobas vivoDx MRSA Roche Molecular Systems, Inc. DEN190016 12/05/2019
cobas EBV, cobas EBV/BKV Control Kit, co Roche Molecular Systems, Inc. DEN200015 07/30/2020
FACTOR V LEIDEN KIT ROCHE DIAGNOSTICS CORP. DEN030005 K033607 12/17/2003
TINA-QUANT HBA1C GEN. 2 TEST SYSTEM Roche Diagnostics DEN130002 K121291 05/23/2013
Elecsys AMH, AMH CalSet, PreciControl AM ROCHE DIAGNOSTICS DEN150057 12/19/2016
XSTAT REVMEDX, INC. DEN130016 K130218 04/03/2014
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