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 K903095
Device Name IL THYROXINE (T4) ASSAY SYSTEM
Applicant
Instrumentation Laboratory CO
113 Hartwell Ave.
P.O. Box 9113
Lexington,  MA  02173
Applicant Contact GEORGE A LYNA
Correspondent
Instrumentation Laboratory CO
113 Hartwell Ave.
P.O. Box 9113
Lexington,  MA  02173
Correspondent Contact GEORGE A LYNA
Regulation Number862.1700
Classification Product Code
KLI  
Date Received07/13/1990
Decision Date 08/23/1990
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
-
-