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 test, equipment, automated bloodborne pathogen
510(k) Number BK100061
Tradename ORTHO VERSEIA¿ Pipetter as part of the ORTHO Summit¿ System
Device Name Test, Equipment, Automated Bloodborne Pathogen
Original Applicant
Ortho-Clinical Diagnostics, Inc.
1001 u.s. highway 202
raritan,  NJ  08869 0606
Classification Product Code
MZA  
Date Received09/30/2010
Decision Date 10/28/2010
Decision substantially equivalent (SE)
Review Advisory Committee Immunology
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 Yes
-
-