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, Free Thyroxine
510(k) Number K920247
Device Name AMERLITE MAB FT4 ASSAY
Applicant
Eastman Kodak Company
343 State St.
Rochester,  NY  14650
Applicant Contact YVONNE ADAIR
Correspondent
Eastman Kodak Company
343 State St.
Rochester,  NY  14650
Correspondent Contact YVONNE ADAIR
Regulation Number862.1695
Classification Product Code
CEC  
Date Received01/21/1992
Decision Date 03/02/1992
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
-
-