• 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
-
21 to 30 of 500 Results *
Decision Date From: 8/1/2003 Decision Date To: 04/23/2024 In Vitro Products: Yes
 < 
 1 
 2 
 3 
 4 
 5 
 6 
 7 
 8 
 9 
 10 
 > 
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]
yumizen c1200 ferritin, yumizen c1200 transferrin, yumizen c1200 rheumatoid factor HORIBA ABX SAS K191562 03/06/2020
yumizen c1200 crp Horiba ABX SAS K191993 10/03/2019
yumizen c1200 crp Horiba ABX SAS K192028 06/25/2020
yumizen c1200 creatinine pap Horiba ABX SAS K193649 05/10/2021
yumizen c1200 calcium as, yumizen c1200 creatinine jaffe Horiba ABX SAS K191396 07/26/2019
yumizen c1200 alp, yumizen c1200 albumin HORIBA ABX SAS K191245 08/30/2019
yo home sperm test MEDICAL ELECTRONIC SYSTEMS, LTD K161493 11/08/2016
yeast traffic light pna fish ADVANDX, INC. K080719 09/12/2008
yeast traffic light pna fish ADVANDX, INC. K093024 07/15/2010
xw-100 automated hematology analyzer, xw qc check SYSMEX AMERICA, INC. K143577 10/12/2015

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