Atellica IM Hepatitis B e Antigen (HBeAg) Assay

FDA Premarket Approval P090024 S010

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

For moving manufacturing of atellica im analyzer’s component/subassembly named autoloader to an internal supplier

DeviceAtellica IM Hepatitis B e Antigen (HBeAg) Assay
Generic NameTest, Hepatitis B (b Core, Be Antigen, Be Antibody, B Core Igm)
ApplicantSIEMENS HEALTHCARE DIAGNOSTICS
Date Received2021-04-01
Decision Date2021-04-27
PMAP090024
SupplementS010
Product CodeLOM 
Advisory CommitteeMicrobiology
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address SIEMENS HEALTHCARE DIAGNOSTICS 511 Benedict Avenue tarrytown, NY 10591

Supplemental Filings

Supplement NumberDateSupplement Type
P090024Original Filing
S010 2021-04-01 30-day Notice
S009 2020-07-31 30-day Notice
S008 2020-03-09 30-day Notice
S007 2020-02-21 30-day Notice
S006 2019-02-01 30-day Notice
S005 2018-07-19 Real-time Process
S004 2017-12-22 Normal 180 Day Track
S003 2017-03-27 30-day Notice
S002 2015-06-11 30-day Notice
S001 2015-05-05 Normal 180 Day Track

NIH GUDID Devices

Device IDPMASupp
00630414591315 P090024 000
00630414531298 P090024 000
00630414599236 P090024 001
00630414599229 P090024 001
00630414301310 P090024 001

© 2021 FDA.report
This site is not affiliated with or endorsed by the FDA.