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 Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine
510(k) Number K103484
Device Name GSP NEONATAL THYROXINE (T4)
Applicant
Wallac Oy, A Subsidiary of Perkinelmer, Inc.
940 Winter St.
Waltham,  MA  02451
Applicant Contact SUSAN K HAMANN
Correspondent
Wallac Oy, A Subsidiary of Perkinelmer, Inc.
940 Winter St.
Waltham,  MA  02451
Correspondent Contact SUSAN K HAMANN
Regulation Number862.1700
Classification Product Code
KLI  
Date Received11/26/2010
Decision Date 04/22/2011
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
-
-