Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
61 to 70 of 500 Results *
Decision Date From: 8/1/2003 Decision Date To: 04/23/2024 In Vitro Products: Yes
 < 
 2 
 3 
 4 
 5 
 6 
 7 
 8 
 9 
 10 
 11 
 > 
Results per Page
New Search  
Export all 500 Records to ExcelExport to Excel | Download Files | More About 510(k)
Device Name
Sort by Device Name [A-Z]
Sort by Device Name [Z-A]
Applicant
Sort by Applicant [A-Z]
Sort by Applicant [Z-A]
510(K)
Number
Sort by 510(k) Number [0-9]
Sort by 510(k) Number [9-0]
Decision
Date
Sort by Decision Date [0-9]
Sort by Decision Date [9-0]
equant system Avails Medical, Inc. K231536 02/08/2024
t2bacteria® panel T2 Biosystems, Inc. K233184 02/08/2024
bühlmann fcal® turbo and calex® cap BÜHLMANN Laboratories AG K232057 02/06/2024
fastep™ pregnancy rapid test strip; fastep™ pregnancy rapid test midstream Assure Tech (Hangzhou) Co., Ltd. K233174 02/05/2024
bd vacutainer® k2 edta blood collection tubes Becton Dickinson and Company K231373 02/02/2024
clearblue® early detection pregnancy test SPD Swiss Precision Diagnostics GmbH K240025 01/31/2024
aptima neisseria gonorrhoeae assay Hologic, Inc. K231329 01/26/2024
egens pregnancy test midstream i, egens pregnancy test midstream ii Nantong Egens Biotechnology Co.,Ltd. K232864 01/26/2024
lifeoutcomes c-quest™ blood culture sampling device LifeOutcomes LLC K231282 01/26/2024
optilite® freelite® kappa free kit, optilite® freelite® lambda free kit The Binding Site Ltd. K231290 01/24/2024

*   The maximium 500 devices meeting your search criteria returned. Please narrow your search.
-
-