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 centrifuge, cell-washing, automated for immuno-hematology
510(k) Number BK020029
Tradename UltraCW (with Software version 3.13)
Device Name Centrifuge, Cell-Washing, Automated for Immunohematology
Original Applicant
Helmer Labs., Inc.
15425 herriman boulevard
noblesville,  IN  46060
Regulation Number864.9285
Classification Product Code
KSN  
Date Received07/08/2002
Decision Date 10/04/2002
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
-
-