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 Colorimetric Method, Lipoproteins
510(k) Number K032798
Device Name DIMENSION AUTOMATED HDL CHOLESTEROL (AHDL) FLEX REAGENT CARTRIDGE (DF48A) CATALOG # DF48A
Applicant
Dade Behring, Inc.
Glasgow Business Community;
Bldg. 500 P.O. Box 6101
Newark,  DE  19714 -6101
Applicant Contact ANDREA M TASKER
Correspondent
Dade Behring, Inc.
Glasgow Business Community;
Bldg. 500 P.O. Box 6101
Newark,  DE  19714 -6101
Correspondent Contact ANDREA M TASKER
Regulation Number862.1475
Classification Product Code
JHM  
Date Received09/09/2003
Decision Date 10/30/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-