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 Biologics Clearance Letters and 510(k) Summaries Back To Search Results
Device Classification Name bone marrow processing device to support hematopoietic reconstitution
510(k) Number BK140191
Tradename Spectra Optia Apheresis System
Device Name Bone marrow processing device to support hematopoietic reconstitution
Original Applicant
Terumo BCT, Inc
10811 w. collins ave.
lakewood,  CO  80215 4498
Regulation Number864.9245
Classification Product Code
PKG  
Date Received11/10/2014
Decision Date 03/09/2015
Decision substantially equivalent (SE)
Classification Advisory Committee Hematology
Review Advisory Committee Hematology
Type 510(k) Traditional
Total Product Life Cycle (TPLC) TPLC Device Report
Reviewed by Third Party No
Expedited Review No
Combination Product No
In Vitro Product No
-
-