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 Calibrators, Drug Mixture
510(k) Number K062121
Device Name DIMENSION VISTA SYSTEM DRUG 2 CALIBRATOR (DRUG 2 CAL - KC420)
Applicant
Dade Behring, Inc.
P.O. Box 6101
Newark,,  DE  19714
Applicant Contact VICTOR M CARRIO
Correspondent
Dade Behring, Inc.
P.O. Box 6101
Newark,,  DE  19714
Correspondent Contact VICTOR M CARRIO
Regulation Number862.3200
Classification Product Code
DKB  
Date Received07/25/2006
Decision Date 08/25/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
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
-
-