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 Flame Photometry, Lithium
510(k) Number K011033
Device Name DIMENSION LITHIUM (LI) FLEX REAGENT CARTRIDGE, MODEL DF 132
Applicant
Dade Behring, Inc.
Glasgow Business Community
Bldg. 500, Ms 514 P.O.Box 6101
Newark,  DE  19714
Applicant Contact RICHARD M VAUGHT
Correspondent
Dade Behring, Inc.
Glasgow Business Community
Bldg. 500, Ms 514 P.O.Box 6101
Newark,  DE  19714
Correspondent Contact RICHARD M VAUGHT
Regulation Number862.3560
Classification Product Code
JIH  
Date Received04/05/2001
Decision Date 06/07/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-