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 Bromcresol Green Dye-Binding, Albumin
510(k) Number K203248
Device Name Albumin BCG2
Applicant
Abbott Ireland Diagnostics Division
Lisnamuck
Longford,  IE
Applicant Contact Suzanne Cheang
Correspondent
Abbott Ireland Diagnostics Division
Lisnamuck
Longford,  IE
Correspondent Contact Suzanne Cheang
Regulation Number862.1035
Classification Product Code
CIX  
Date Received11/04/2020
Decision Date 11/23/2021
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
-
-