Elecsys HBsAg II

FDA Premarket Approval P160019 S013

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.

Pre-market Approval Supplement Details

To improve and expand manufacturing of kit components

DeviceElecsys HBsAg II
Generic NameTest, Hepatitis B (b Core, Be Antigen, Be Antibody, B Core Igm)
Date Received2021-11-29
Decision Date2021-12-16
Product CodeLOM 
Advisory CommitteeMicrobiology
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address ROCHE DIAGNOSTICS, INC. 9115 Hague Road indianapolis, IN 46038

Supplemental Filings

Supplement NumberDateSupplement Type
P160019Original Filing
S013 2021-11-29 30-day Notice
S012 2021-08-02 Normal 180 Day Track
S011 2019-11-27 Normal 180 Day Track
S010 2019-09-03 Normal 180 Day Track
S009 2018-10-26 Normal 180 Day Track No User Fee
S008 2018-10-09 30-day Notice
S007 2018-04-17 Real-time Process
S006 2017-10-11 Real-time Process
S005 2017-08-03 30-day Notice
S004 2017-07-28 Normal 180 Day Track
S003 2017-07-28 Normal 180 Day Track
S002 2017-05-24 30-day Notice
S001 2017-05-09 Normal 180 Day Track


Device IDPMASupp
07613336106402 P160019 000
07613336106396 P160019 000
04015630911110 P160019 000
07613336198285 P160019 010
07613336198278 P160019 010
07613336168103 P160019 010
07613336172902 P160019 011
07613336164372 P160019 011

© 2022 FDA.report
This site is not affiliated with or endorsed by the FDA.