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 Olive Oil Emulsion (Turbidimetric), Lipase
510(k) Number K901858
Device Name MODIFIED LABELING FOR ACA LIPASE ANALYTICAL TEST
Applicant
E.I. DUPONT DE NEMOURS & CO., INC.
DU PONT-BMP22/1152
WILMINGTON,  DE  19880
Applicant Contact CHRISTOPHER BENTSEN
Correspondent
E.I. DUPONT DE NEMOURS & CO., INC.
DU PONT-BMP22/1152
WILMINGTON,  DE  19880
Correspondent Contact CHRISTOPHER BENTSEN
Regulation Number862.1465
Classification Product Code
CET  
Date Received04/24/1990
Decision Date 06/12/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-