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 calibrator, multi-analyte mixture
510(k) Number K140790
Device Name Dimension Vista Chemistry 1 Calibrator (CHEM 1 CAL), Dimension Vista Magnesium Flex reagent cartridge (MG)
Applicant
SIEMENS HEALTHCARE DIAGNOSTICS
500 GBC DRIVE M/S 514
NEWARK,  DE  19714
Applicant Contact HELEN M LEE
Correspondent
SIEMENS HEALTHCARE DIAGNOSTICS
500 GBC DRIVE M/S 514
NEWARK,  DE  19714
Correspondent Contact HELEN M LEE
Regulation Number862.1150
Classification Product Code
JIX  
Subsequent Product Code
JGJ  
Date Received03/31/2014
Decision Date 06/15/2015
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
-
-