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 test, cystatin c
510(k) Number K063351
Device Name DIMENSION VISTA CYSC FLEX REAGENT CARTRIDGE, PROTEIN 3 CALIBRATOR AND CYSTATIN CONTROL LOW AND HIGH
Applicant
DADE BEHRING, INC.
P.O. BOX 6101
NEWARK,,  DE  19714
Applicant Contact KATHLEEN A DRAY-LYONS
Correspondent
DADE BEHRING, INC.
P.O. BOX 6101
NEWARK,,  DE  19714
Correspondent Contact KATHLEEN A DRAY-LYONS
Regulation Number862.1225
Classification Product Code
NDY  
Subsequent Product Codes
JIX   JJY  
Date Received11/06/2006
Decision Date 01/22/2007
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
Recalls CDRH Recalls
-
-