Atellica IM HBsAgII (HBsII)/Atellica IM HBsAg Confirmatory

Test, Hepatitis B (b Core, Be Antigen, Be Antibody, B Core Igm)

FDA Premarket Approval P110041 S006

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 the placement of these assays on the atellica solution.

• Device: Atellica IM HBsAgII (HBsII)/Atellica IM HBsAg Confirmatory
• Classification Name: Test, Hepatitis B (b Core, Be Antigen, Be Antibody, B Core Igm)
• Generic Name: Test, Hepatitis B (b Core, Be Antigen, Be Antibody, B Core Igm)
• Applicant: SIEMENS CORP.
• Date Received: 2018-07-19
• Decision Date: 2018-09-11
• PMA: P110041
• Supplement: S006
• Product Code: LOM
• Advisory Committee: Microbiology
• Supplement Type: Real-time Process
• Supplement Reason: Change Design/components/specifications/material
• Expedited Review: No
• Combination Product: No
• Applicant Address: SIEMENS CORP. 511 Benedict Avenue tarrytown, NY 10591

Supplemental Filings

Supplement Number	Date	Supplement Type
P110041		Original 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 ID	PMA	Supp
00630414599274	P110041	000
00630414578170	P110041	000
00630414301327	P110041	000