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 Assay, Porphyrin, Spectrophotometry, Lithium
510(k) Number K112142
Device Name DIMENSION VISTA LITHIUM FLEX REAGENT CARTRIDGE
Applicant
Siemens Healthcare Diagnostics
P.O. Box 6101
Newark,  DE  19714 -6101
Applicant Contact ROSE T MARINELLI
Correspondent
Siemens Healthcare Diagnostics
P.O. Box 6101
Newark,  DE  19714 -6101
Correspondent Contact ROSE T MARINELLI
Regulation Number862.3560
Classification Product Code
NDW  
Subsequent Product Code
JIX  
Date Received07/26/2011
Decision Date 11/04/2011
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
Recalls CDRH Recalls
-
-