• 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 Ammonium Molybdate And Ammonium Vanadate, Phospholipids
510(k) Number K884169
Device Name DU PONT ANALYST THYROID ROTOR
Applicant
The DU Pont Co.
Chestnut Run Plz.
P.O. Box 80715
Wilmington,  DE 
Applicant Contact RICHARD M VAUGHT
Correspondent
The DU Pont Co.
Chestnut Run Plz.
P.O. Box 80715
Wilmington,  DE 
Correspondent Contact RICHARD M VAUGHT
Regulation Number862.1575
Classification Product Code
CEL  
Date Received10/04/1988
Decision Date 01/24/1989
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
-
-