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 system, processing for frozen blood
510(k) Number BK180254
Tradenames Glycerolyte 57 Solution, 400 mL, Glycerolyte 57 Solution, 500 mL
Device Name System, Processing for Frozen Blood
Original Applicant
Fresenius Kabi AG
three corporate dr
lake zurich,  IL  60047
Regulation Number864.9145
Classification Product Code
KSW  
Date Received09/04/2018
Decision Date 12/03/2018
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
-
-