Atellica IM Hepatitis B surface Antigen II (HBs11) and Atellica IM Hepatitis B surface Antigen 11 confirmatory (HBs11 Co

FDA Premarket Approval P110041 S009

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

Approval for a modification to the manufacturing process to add a second manufacturing site for optional sample handling subsystem (atellica direct load) for the atellica im analyzer (immunoassay module)

DeviceAtellica IM Hepatitis B surface Antigen II (HBs11) and Atellica IM Hepatitis B surface Antigen 11 confirmatory (HBs11 Co
Generic NameTest, Hepatitis B (b Core, Be Antigen, Be Antibody, B Core Igm)
ApplicantSIEMENS CORP.
Date Received2020-03-09
Decision Date2020-04-03
PMAP110041
SupplementS009
Product CodeLOM 
Advisory CommitteeMicrobiology
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address SIEMENS CORP. 511 Benedict Avenue tarrytown, NY 10591

Supplemental Filings

Supplement NumberDateSupplement Type
P110041Original Filing
S013 2022-03-22 30-day Notice
S012 2021-04-01 30-day Notice
S011 2020-12-22 Real-time Process
S010 2020-07-31 30-day Notice
S009 2020-03-09 30-day Notice
S008 2020-02-21 30-day Notice
S007 2019-02-01 30-day Notice
S006 2018-07-19 Real-time Process
S005 2018-04-24 30-day Notice
S004 2017-07-24 Normal 180 Day Track
S003 2015-07-13 Normal 180 Day Track
S002 2015-06-11 30-day Notice
S001 2014-10-02 Real-time Process

NIH GUDID Devices

Device IDPMASupp
00630414599274 P110041 000
00630414578170 P110041 000
00630414301327 P110041 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.