• 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 | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 


New Search Back To Search Results
Device Classification Name calibrators, drug mixture
510(k) Number K120936
Device Name ABBOTT TDM MULTICONSTITUENT CALIBRATOR, THERMO SCIENTIFIC QMS MULTI-CONSTITUENT CALIBRATORS
Original Applicant
Microgenics Corporation
46360 fremont blvd.
fremont,  CA  94538
Original Contact karen lee
Regulation Number862.3200
Classification Product Code
DKB  
Date Received03/28/2012
Decision Date 12/13/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
summary summary
FDA Review Decision Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
-
-