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 container, empty, for collection & processing of blood & blood components
510(k) Number BK251160
Tradename Adaptive Nomogram Bottle
Device Name Container, Empty, For the Collection '& Processing of Blood/Blood Components
Original Applicant
Fresenius Kabi AG
else-kroner-strasse 1
bad homburg,  61346, 
Regulation Number864.9100
Classification Product Code
KSR  
Date Received01/24/2025
Decision Date 02/21/2025
Decision substantially equivalent (SE)
Classification Advisory Committee Hematology
Review Advisory Committee Hematology
Type 510(k) Special
Total Product Life Cycle (TPLC) TPLC Device Report
Reviewed by Third Party No
Expedited Review No
Combination Product No
In Vitro Product No
-
-