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

Premarket Approval (PMA)
  • 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 Back to Search Results
Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceELECSYS ANTI-HBS
Generic NameTest, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
Regulation Number866.3172
ApplicantRoche Diagnostics Corp.
9115 Hague Rd.
Indianapolis, IN 46250
PMA NumberP010054
Supplement NumberS023
Date Received04/04/2014
Decision Date06/12/2014
Reclassified Date10/20/2025
Product Code LOM 
Advisory Committee Microbiology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR RELEASE OF COBAS 8000 SOFTWARE VERSION 04-01 AND COBAS 8000 DATA MANAGER SOFTWARE VERSION 1.03.
-
-