• 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 counter, differential cell
510(k) Number BK010044
Tradename stemONE System for EPICS XL/ XL-MCL Flow Cytometry Systems
Device Name Counter, Differential Cell
Original Applicant
Beckman Coulter, Inc.
11800 sw 147 avenue
(m/c: 31-b06)
miami,  FL  33196 2500
Regulation Number864.5220
Classification Product Code
Date Received10/16/2001
Decision Date 05/20/2002
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 Yes