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, Free Thyroxine
510(k) Number K123379
Device Name ABBOTT ARCHITECT FREE T4
Applicant
Abbott Laboratories
100 Abbott Park Rd.
Abbott Park,  IL  60064
Applicant Contact JACEK GORZOWSKI
Correspondent
Abbott Laboratories
100 Abbott Park Rd.
Abbott Park,  IL  60064
Correspondent Contact JACEK GORZOWSKI
Regulation Number862.1695
Classification Product Code
CEC  
Subsequent Product Codes
JIT   JJX  
Date Received11/01/2012
Decision Date 11/27/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-