IMMULITE 2000 HBsAg Confirmatory

FDA Premarket Approval P010050 S018

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

To remove select inspection criteria from the raw materials used to manufacture immulite substrate reagent

DeviceIMMULITE 2000 HBsAg Confirmatory
Generic NameTest, Hepatitis B (b Core, Be Antigen, Be Antibody, B Core Igm)
ApplicantSiemens Healthcare Diagnostics Products, LTD
Date Received2020-08-12
Decision Date2020-09-08
PMAP010050
SupplementS018
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
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
00630414947433 P010050 001
00630414971551 P010050 001
00630414971438 P010050 001
00630414971544 P010050 001
00630414971551 P010050 001
00630414971438 P010050 001
00630414971544 P010050 001
00630414971551 P010050 001
00630414971438 P010050 001
00630414971544 P010050 001
00630414971551 P010050 001
00630414971438 P010050 001
00630414971544 P010050 001
00630414971544 P010050 001
00630414971438 P010050 001
00630414947433 P010050 001
00630414947433 P010050 001
00630414947433 P010050 001
00630414947433 P010050 001
00630414947433 P010050 001
00630414947433 P010050 001
00630414947433 P010050 001
00630414947433 P010050 001
00630414947433 P010050 001
00630414947433 P010050 001
00630414947433 P010050 001
00630414947433 P010050 001
00630414971551 P010050 001
00630414971438 P010050 001
00630414971544 P010050 001
00630414971544 P010050 001
00630414971551 P010050 001
00630414971438 P010050 001
00630414971544 P010050 001
00630414971551 P010050 001
00630414947433 P010050 001
00630414971438 P010050 001
00630414971544 P010050 001
00630414971551 P010050 001
00630414947433 P010050 001
00630414971438 P010050 001
00630414971544 P010050 001
00630414971438 P010050 001
00630414971551 P010050 001
00630414971551 P010050 001
00630414971438 P010050 001
00630414971544 P010050 001
00630414971551 P010050 001
00630414971438 P010050 001
00630414971544 P010050 001
00630414971551 P010050 001
00630414971438 P010050 001
00630414971544 P010050 001
00630414971551 P010050 001
00630414971438 P010050 001
00630414971544 P010050 001
00630414971551 P010050 001

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