ADVIA Centaur and Atellica IM HBc Total

FDA Premarket Approval P040004 S016

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

Scale-up and implementation of a common mixing process for all kit bulk reagents

DeviceADVIA Centaur and Atellica IM HBc Total
Generic NameTest, Hepatitis B (b Core, Be Antigen, Be Antibody, B Core Igm)
ApplicantSIEMENS HEALTHCARE DIAGNOSTICS
Date Received2020-02-21
Decision Date2020-03-19
PMAP040004
SupplementS016
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 333 Coney Street walpole, MA 02032-1516

Supplemental Filings

Supplement NumberDateSupplement Type
P040004Original Filing
S016 2020-02-21 30-day Notice
S015 2019-02-01 30-day Notice
S014 2018-07-19 Real-time Process
S013 2017-07-17 Normal 180 Day Track
S012 2015-07-13 Normal 180 Day Track
S011 2015-06-11 30-day Notice
S010 2014-09-09 Normal 180 Day Track
S009 2012-03-26 Normal 180 Day Track No User Fee
S008 2012-01-09 30-day Notice
S007 2010-01-08 30-day Notice
S006 2009-05-18 Normal 180 Day Track
S005 2009-03-31 Normal 180 Day Track
S004 2009-03-09 Normal 180 Day Track No User Fee
S003 2009-02-04 30-day Notice
S002 2008-08-26 Normal 180 Day Track
S001

NIH GUDID Devices

Device IDPMASupp
00630414498089 P040004 000
00630414498089 P040004 000
00630414599212 P040004 002
00630414599205 P040004 002
00630414498096 P040004 002
00630414599212 P040004 002
00630414599205 P040004 002
00630414498096 P040004 002

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