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 Kit, Test,Alpha-Fetoprotein For Testicular Cancer
510(k) Number K213626
Device Name VITROS AFP
Applicant
Ortho Clinical Diagnostics
Felindre Meadows
Pencoed,  GB CF35 5pz
Applicant Contact Declan Hynes
Correspondent
Ortho Clinical Diagnostics
Felindre Meadows
Pencoed,  GB CF35 5pz
Correspondent Contact Declan Hynes
Regulation Number866.6010
Classification Product Code
LOJ  
Date Received11/17/2021
Decision Date 06/15/2022
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
Predetermined Change
Control Plan Authorized		 No
-
-