ADVIA Centaur HBsAgII/Confirmatory Readypack Reagents and QC Material

FDA Premarket Approval P110041 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

Procedure for testing raw materials, in-process and final products

DeviceADVIA Centaur HBsAgII/Confirmatory Readypack Reagents and QC Material
Generic NameTest, Hepatitis B (b Core, Be Antigen, Be Antibody, B Core Igm)
ApplicantSIEMENS CORP.
Date Received2020-07-31
Decision Date2020-08-25
PMAP110041
SupplementS010
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
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
00630414599274 P110041 000
00630414578170 P110041 000
00630414599274 P110041 000
00630414578170 P110041 000
00630414599274 P110041 000
00630414578170 P110041 000
00630414599274 P110041 000
00630414578170 P110041 000
00630414599274 P110041 000
00630414578170 P110041 000
00630414599274 P110041 000
00630414578170 P110041 000
00630414599274 P110041 000
00630414578170 P110041 000
00630414599274 P110041 000
00630414578170 P110041 000
00630414599274 P110041 000
00630414578170 P110041 000
00630414599274 P110041 000
00630414578170 P110041 000
00630414599274 P110041 000
00630414578170 P110041 000
00630414599274 P110041 000
00630414578170 P110041 000
00630414599274 P110041 000
00630414578170 P110041 000
00630414599274 P110041 000
00630414578170 P110041 000
00630414578170 P110041 000

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