ADVIA CENTAUR ANTI-HBS READYPACK REAGENTS & CALIBRATORS

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

FDA Premarket Approval P030029 S001

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

Approval for an additional component supplier.

DeviceADVIA CENTAUR ANTI-HBS READYPACK REAGENTS & CALIBRATORS
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
Date Received2007-03-14
Decision Date2007-08-02
PMAP030029
SupplementS001
Product CodeLOM
Advisory CommitteeMicrobiology
Supplement Type135 Review Track For 30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address SIEMENS HEALTHCARE DIAGNOSTICS 333 Coney Street walpole, MA 02032

Supplemental Filings

Supplement NumberDateSupplement Type
P030029Original 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 IDPMASupp
00630414471860 P030029 000
00630414471914 P030029 003
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