ADVIA CENTAUR ANTI-HBS ASSAY

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

FDA Premarket Approval P030029 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

Change of raw material used in the production of the lite reagent buffer.

• Device: ADVIA CENTAUR ANTI-HBS ASSAY
• Classification Name: Test, Hepatitis B (b Core, Be Antigen, Be Antibody, B Core Igm)
• Generic Name: Test, Hepatitis B (b Core, Be Antigen, Be Antibody, B Core Igm)
• Applicant: SIEMENS HEALTHCARE DIAGNOSTICS
• Date Received: 2011-02-16
• Decision Date: 2011-03-14
• PMA: P030029
• Supplement: S012
• Product Code: LOM
• Advisory Committee: Microbiology
• Supplement Type: 30-day Notice
• Supplement Reason: Process Change - Manufacturer/sterilizer/packager/supplier
• Expedited Review: No
• Combination Product: No
• Applicant Address: SIEMENS HEALTHCARE DIAGNOSTICS 333 Coney Street walpole, MA 02032

Supplemental Filings

Supplement Number	Date	Supplement Type
P030029		Original Filing
S013	2012-03-26	Normal 180 Day Track No User Fee
S012	2011-02-16	30-day Notice
S011	2010-09-29	30-day Notice
S010
S009	2009-09-28	Normal 180 Day Track
S008	2009-08-21	30-day Notice
S007	2009-05-18	Normal 180 Day Track
S006	2009-03-31	Normal 180 Day Track
S005	2009-03-03	Normal 180 Day Track No User Fee
S004	2008-09-18	Normal 180 Day Track
S003	2008-08-11	Normal 180 Day Track
S002
S001	2007-03-14	135 Review Track For 30-day Notice

NIH GUDID Devices

Device ID	PMA	Supp
00630414471860	P030029	000
00630414471914	P030029	003