• 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 separator, automated, blood cell and plasma, therapeutic
510(k) Number K113480
Device Name SPECTRA OPTIA APHERESIS SYSTEM
Original Applicant
CARIDIANBCT, INC.
10811 w. collins ave
lakewood,  CO  80215
Original Contact tina o'brien
Classification Product Code
LKN  
Date Received11/23/2011
Decision Date 01/20/2012
Decision substantially equivalent (SESE)
510k Review Panel Gastroenterology/Urology
summary summary
Type Special
Reviewed by Third Party No
Combination Product No
-
-