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, Total Triiodothyronine
510(k) Number K852537
Device Name T-3 RIASSAY
Applicant
Ria Diagnostics
8226 Allport Aveneue
Santa Fe Springs,  CA  90670
Applicant Contact GEORGE L BROUSSALIA
Correspondent
Ria Diagnostics
8226 Allport Aveneue
Santa Fe Springs,  CA  90670
Correspondent Contact GEORGE L BROUSSALIA
Regulation Number862.1710
Classification Product Code
CDP  
Date Received06/14/1985
Decision Date 08/12/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-