• 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 media, culture, ex vivo, tissue and cell
510(k) Number K113566
Device Name OPTMIZER CTS T-CELL EXPANSION SERUM FREE MEDIUM
Original Applicant
LIFE TECHNOLOGIES, INC.
3175 staley rd.
grand island,  NY  14072
Original Contact kelli l tanzella
Regulation Number876.5885
Classification Product Code
NDS  
Date Received12/02/2011
Decision Date 06/21/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-