Atellica IM Hepatitis B core IgM (aHBcM) Assay

FDA Premarket Approval P030040 S020

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 core IgM (aHBcM) 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
PMAP030040
SupplementS020
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
P030040Original Filing
S020 2021-04-01 30-day Notice
S019 2020-12-22 Real-time Process
S018 2020-07-31 30-day Notice
S017 2020-03-09 30-day Notice
S016 2020-02-21 30-day Notice
S015 2019-02-01 30-day Notice
S014 2018-08-15 Normal 180 Day Track No User Fee
S013 2018-07-19 Real-time Process
S012 2017-06-16 Normal 180 Day Track
S011 2016-07-05 Normal 180 Day Track
S010 2015-06-11 30-day Notice
S009 2015-05-14 Normal 180 Day Track
S008 2012-03-26 Normal 180 Day Track No User Fee
S007 2010-02-18 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 2008-08-11 Normal 180 Day Track
S001

NIH GUDID Devices

Device IDPMASupp
00630414978017 P030040 000
00630414597805 P030040 000
00630414470504 P030040 000
00630414597799 P030040 002
00630414470498 P030040 002
00630414301266 P030040 002

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