IMMULITE 2000 Anti-HBcM

FDA Premarket Approval P010053 S012

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 Anti-HBcM
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
PMAP010053
SupplementS012
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
P010053Original Filing
S016 2022-09-15 30-day Notice
S015
S014 2022-02-28 30-day Notice
S013 2020-12-22 Real-time Process
S012 2020-08-12 30-day Notice
S011 2019-11-25 30-day Notice
S010 2011-12-19 135 Review Track For 30-day Notice
S009 2011-08-16 30-day Notice
S008 2011-08-08 30-day Notice
S007 2011-02-18 Real-time Process
S006 2009-11-02 Normal 180 Day Track No User Fee
S005
S004 2008-11-10 Normal 180 Day Track No User Fee
S003 2005-08-17 Special (immediate Track)
S002
S001 2002-11-20 Real-time Process

NIH GUDID Devices

Device IDPMASupp
00630414977737 P010053 001
00630414977720 P010053 001
00630414960975 P010053 001

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