ADVIA Centaur HBsAg II(HBsII), ADVIA Centaur HBsAg Confirmatory, ADVIA Centaur HBsAg Quality Control Material, Atellica

FDA Premarket Approval P110041 S011

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

This supplement is for labeling changes as a result of biotin interference testing.

DeviceADVIA Centaur HBsAg II(HBsII), ADVIA Centaur HBsAg Confirmatory, ADVIA Centaur HBsAg Quality Control Material, Atellica
Generic NameTest, Hepatitis B (b Core, Be Antigen, Be Antibody, B Core Igm)
ApplicantSIEMENS CORP.
Date Received2020-12-22
Decision Date2021-03-11
PMAP110041
SupplementS011
Product CodeLOM 
Advisory CommitteeMicrobiology
Supplement TypeReal-time Process
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
Expedited ReviewNo
Combination Product No
Applicant Address SIEMENS CORP. 511 Benedict Avenue tarrytown, NY 10591

Supplemental Filings

Supplement NumberDateSupplement Type
P110041Original Filing
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

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