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 Diazo Colorimetry, Bilirubin
510(k) Number K223324
Device Name Total Bilirubin2
Applicant
Abbott Ireland Diagnostics Division
Lisnarnuck
Longsford,  IE
Applicant Contact Magdalena Suszko
Correspondent
Abbott Ireland Diagnostics Division
Lisnarnuck
Longsford,  IE
Correspondent Contact Magdalena Suszko
Regulation Number862.1110
Classification Product Code
CIG  
Subsequent Product Code
MQM  
Date Received10/31/2022
Decision Date 12/29/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-