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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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1 to 10 of 412 results
Decision Date To: 05/01/2024
 
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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)
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Decision
Date
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Rho 16 Bit Inc DEN230023 04/09/2024
23ANDME PERSONAL GENOME SERVICE (HEREINA 23andMe DEN140044 02/19/2015
23andMe Personal Genome Service (PGS) Ge 23andMe, Inc. DEN160026 04/06/2017
23andMe PGS Genetic Health Risk Report f 23andMe, Inc. DEN170046 03/06/2018
23andMe Personal Genome Service (PGS) Ph 23andMe, Inc. DEN180028 10/31/2018
3M N95 HOME RESPIRATOR WITH FLUID RESIST 3M COMPANY DEN060009 K062070 05/08/2007
THE 3PM EGG MACHINE 3PM CO., INC. DEN990005 K984637 08/20/1999
MANDOMETER III AB MANDO DEN070014 K063817 03/31/2011
Vitamin D 200M Assay for the Topaz Syste AB SCIEX LLC DEN170019 05/18/2017
VYSIS EGR1 FISH PROBE KIT - SC (SPECIMEN ABBOTT MOLECULAR, INC. DEN130010 K123951 07/29/2013
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