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
-
1 to 10 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]
'rapidtec 4' test AMERICAN BIO MEDICA CORP. K041712 11/03/2004
1,25-dihydroxy vitamin d eia IMMUNODIAGNOSTIC SYSTEMS LTD. K051110 07/06/2005
20g open-system ally device kit (av100000), 22g open-system ally device kit (av110000) AVIA Vascular K220258 07/14/2022
23andme personal genome service (pgs) pharmacogenetic reports 23andMe, Inc. K193492 08/17/2020
23andme personal genome service (pgs) pharmacogenetic reports 23andMe, Inc. K221885 10/26/2022
23andme pgs genetic risk report for hereditary prostate cancer (hoxb13-related) 23andMe, Inc. K211499 01/06/2022
23andme® personal genome service® (pgs®) cancer predisposition genetic health risk report for brca1/brca2 (selected variants) 23andMe, Inc. K223597 08/31/2023
25-hydroxy vitamin ds eia IMMUNODIAGNOSTIC SYSTEMS LTD. K142351 08/25/2015
25-oh vitamin d elisa EUROIMMUN US K123660 07/17/2013
25oh vitamin d total elisa test DIASOURCE IMMUNOASSAYS, S.A. K123364 07/15/2013

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