• 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 separator, automated, blood cell, diagnostic
510(k) Number BK190351
Tradenames ALYX 2RBC LR Kit , ALYX Component Collection System , ALYX RBC/Plasma Kit , ALYX Red Kit
Device Name Automated Blood Cell Separators
Original Applicant
Fresenius Kabi USA LLC.
three corporate drive
lake zurich,  IL  60047
Regulation Number864.9245
Classification Product Code
Date Received05/08/2019
Decision Date 06/06/2019
Decision substantially equivalent (SE)
Classification Advisory Committee Hematology
Review Advisory Committee Hematology
Type 510(k) Special
Reviewed by Third Party No
Expedited Review No
Combination Product No