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 K894993
Device Name STRATUS(R) TOTAL TRIIODOTHYRONINE (T3) F.E.I.
Applicant
Baxter Healthcare Corp
P.O. Box 520672
Miami,  FL  33152
Applicant Contact NANCY A HORNBAKER
Correspondent
Baxter Healthcare Corp
P.O. Box 520672
Miami,  FL  33152
Correspondent Contact NANCY A HORNBAKER
Regulation Number862.1710
Classification Product Code
CDP  
Date Received08/08/1989
Decision Date 10/13/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-