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
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name radioimmunoassay (two-site solid phase), ferritin
510(k) Number K234052
Device Name Access Ferritin
Applicant
Beckman Coulter, Inc
1000 Lake Hazeltine Drive
Chaska,  MN  55318
Applicant Contact Kate Oelberg
Correspondent
Beckman Coulter, Inc
1000 Lake Hazeltine Drive
Chaska,  MN  55318
Correspondent Contact Kate Oelberg
Regulation Number866.5340
Classification Product Code
JMG  
Date Received12/21/2023
Decision Date 03/20/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-