• 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 container, empty, for collection & processing of blood & blood components
510(k) Number BK190362
Tradename Plasmalink Bottle with Locking Luer Adapter
Device Name Container, Empty, For the Collection '& Processing of Blood/Blood Components
Original Applicant
Fresenius Kabi AG
three corporate dr
lake zurich,  IL  60047 US
Current 510(k) Holder *
Fresenius Kabi AG
61346 bad homburg,  GERMANY  NONE
No 510(k) contact with active listings identified
Regulation Number864.9100
Classification Product Code
Date Received06/24/2019
Decision Date 07/19/2019
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
* Based on currently available data in Establishment Registration and Device Listing