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, Thyroid-Stimulating Hormone
510(k) Number K941146
Device Name DUPONT ACA PLUS THYROID STIMULATING HORMONE SYSTEM
Applicant
Dupont Medical Products
P.O. Box 80022, Bmp 22-1174
Wilmington,  DE  19880
Applicant Contact REBECCA S AYASH
Correspondent
Dupont Medical Products
P.O. Box 80022, Bmp 22-1174
Wilmington,  DE  19880
Correspondent Contact REBECCA S AYASH
Regulation Number862.1690
Classification Product Code
JLW  
Date Received03/10/1994
Decision Date 10/03/1994
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
-
-