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
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
00630414977720 P010053 001
00630414977720 P010053 001
00630414977737 P010053 001
00630414977720 P010053 001
00630414977737 P010053 001
00630414977720 P010053 001
00630414977737 P010053 001
00630414977720 P010053 001
00630414977737 P010053 001
00630414977720 P010053 001
00630414977737 P010053 001
00630414977720 P010053 001
00630414977737 P010053 001
00630414977720 P010053 001
00630414977737 P010053 001
00630414977720 P010053 001
00630414977737 P010053 001
00630414977720 P010053 001
00630414977737 P010053 001
00630414977720 P010053 001
00630414977737 P010053 001
00630414977737 P010053 001
00630414977720 P010053 001
00630414960975 P010053 001
00630414960975 P010053 001
00630414960975 P010053 001
00630414960975 P010053 001
00630414960975 P010053 001
00630414977720 P010053 001
00630414977737 P010053 001
00630414960975 P010053 001
00630414977720 P010053 001
00630414960975 P010053 001
00630414960975 P010053 001
00630414977737 P010053 001
00630414977720 P010053 001
00630414977737 P010053 001
00630414960975 P010053 001
00630414960975 P010053 001
00630414960975 P010053 001
00630414960975 P010053 001
00630414960975 P010053 001
00630414960975 P010053 001
00630414977737 P010053 001

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