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 HBsAg II/Elecsys HBsAg Confirmatory Test/ PreciControl HBsAg II
Generic NameTest, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
Regulation Number866.3172
ApplicantRoche Diagnostics, Inc.
9115 Hague Rd.
Indianapolis, IN 46038
PMA NumberP160019
Supplement NumberS004
Date Received07/28/2017
Decision Date12/29/2017
Reclassified Date10/20/2025
Product Code LOM 
Advisory Committee Microbiology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for Migration of Elecsys HBsAg II, Elecsys HBsAg Confirmatory Test and PreciControl HBsAg II on the cobas e 801 immunoassay analyzer.
-
-