ADVIA Centaur and Atellica IM HCV

FDA Premarket Approval P030056 S015

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

Scale-up and implementation of a common mixing process for all kit bulk reagents

DeviceADVIA Centaur and Atellica IM HCV
Generic NameAssay, Enzyme Linked Immunosorbent, Hepatitis C Virus
ApplicantSIEMENS HEALTHCARE DIAGNOSTICS
Date Received2020-02-21
Decision Date2020-03-19
PMAP030056
SupplementS015
Product CodeMZO 
Advisory CommitteeMicrobiology
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address SIEMENS HEALTHCARE DIAGNOSTICS 333 Coney Street walpole, MA 02032-1516

Supplemental Filings

Supplement NumberDateSupplement Type
P030056Original Filing
S015 2020-02-21 30-day Notice
S014 2019-02-01 30-day Notice
S013 2018-07-19 Real-time Process
S012
S011 2017-09-29 Normal 180 Day Track
S010 2015-06-11 30-day Notice
S009 2015-05-01 Normal 180 Day Track
S008 2014-09-15 Normal 180 Day Track
S007 2012-03-26 Normal 180 Day Track No User Fee
S006 2009-05-18 Normal 180 Day Track
S005 2009-03-31 Normal 180 Day Track
S004 2009-03-09 Normal 180 Day Track No User Fee
S003 2009-02-04 30-day Notice
S002 2008-08-25 Normal 180 Day Track
S001

NIH GUDID Devices

Device IDPMASupp
00630414597867 P030056 002
00630414473161 P030056 002
00630414278759 P030056 002
00630414278742 P030056 002
00630414597867 P030056 002
00630414473161 P030056 002
00630414278759 P030056 002
00630414278742 P030056 002

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