• 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 blood establishment computer software and accessories
510(k) Number BK010025
Tradename Chiron Procleix NAT Tracker
Device Name Blood Establishment Computer Software and Accessories
Original Applicant
Chiron Corporation
4560 horton street
emeryville,  CA  94608 2916
Regulation Number864.9165
Classification Product Code
Date Received07/23/2001
Decision Date 01/03/2002
Decision substantially equivalent (SE)
Classification Advisory Committee Hematology
Review Advisory Committee Hematology
Type 510(k) Abbreviated
Total Product Life Cycle (TPLC) TPLC Device Report
Reviewed by Third Party No
Expedited Review No
Combination Product No
In Vitro Product No