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 K896865
Device Name VITRO T4-EIA-XT
Applicant
In Vitro Diagnostics, Inc.
Bldg. B Suite 1
Bldg. B Suite 1
Littleton,  CO  80120
Applicant Contact MUSICK, PH.D.
Correspondent
In Vitro Diagnostics, Inc.
Bldg. B Suite 1
Bldg. B Suite 1
Littleton,  CO  80120
Correspondent Contact MUSICK, PH.D.
Regulation Number862.1700
Classification Product Code
KLI  
Date Received12/06/1989
Decision Date 01/30/1990
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
-
-