IMMULITE/IMMULITE 1000 & IMMULITE 2000 HBSAG & 2000 HBSAG CONFIRMATORY

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

FDA Premarket Approval P010050 S014

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

Implementation of an incoming specification for zinc content for 2-amino-2-methyl-1- propanol (amp) buffer and elimination of substrate verification testing.

DeviceIMMULITE/IMMULITE 1000 & IMMULITE 2000 HBSAG & 2000 HBSAG CONFIRMATORY
Classification NameTest, Hepatitis B (b Core, Be Antigen, Be Antibody, B Core Igm)
Generic NameTest, Hepatitis B (b Core, Be Antigen, Be Antibody, B Core Igm)
ApplicantSiemens Healthcare Diagnostics Products, LTD
Date Received2011-08-16
Decision Date2011-09-13
PMAP010050
SupplementS014
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 Products, LTD glyn Rhonwy llanberis, Caernarfon LL55

Supplemental Filings

Supplement NumberDateSupplement Type
P010050Original Filing
S021 2022-09-15 30-day Notice
S020
S019 2021-05-12 30-day Notice
S018 2020-08-12 30-day Notice
S017 2019-11-25 30-day Notice
S016 2014-07-02 135 Review Track For 30-day Notice
S015 2011-12-19 135 Review Track For 30-day Notice
S014 2011-08-16 30-day Notice
S013 2011-08-08 30-day Notice
S012 2011-02-18 Real-time Process
S011 2010-09-29 Normal 180 Day Track
S010 2009-11-02 Normal 180 Day Track No User Fee
S009
S008 2009-05-13 Real-time Process
S007 2008-12-02 Normal 180 Day Track
S006 2008-11-10 Normal 180 Day Track No User Fee
S005 2006-08-04 30-day Notice
S004
S003 2003-05-22 30-day Notice
S002
S001 2002-11-20 Real-time Process

NIH GUDID Devices

Device IDPMASupp
00630414971551 P010050 001
00630414971544 P010050 001
00630414971438 P010050 001
00630414947433 P010050 001

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