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 Lipase-Esterase, Enzymatic, Photometric, Lipase
510(k) Number K952816
Device Name LIPASE FLEX REAGENT CARTRIDGE
Applicant
Dupont Medical Products
Barley Mill Plz.
P22-1170
Wilmington,  DE  19880
Applicant Contact CAROLYN K GEORGE
Correspondent
Dupont Medical Products
Barley Mill Plz.
P22-1170
Wilmington,  DE  19880
Correspondent Contact CAROLYN K GEORGE
Regulation Number862.1465
Classification Product Code
CHI  
Date Received06/20/1995
Decision Date 07/20/1995
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
Recalls CDRH Recalls
-
-