HERCEPTEST

System, Test, Her-2/neu, Ihc

FDA Premarket Approval P980018 S013

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 labeling changes that add precaution and an instruction that is intended to enhance the safe use of herceptest.

DeviceHERCEPTEST
Classification NameSystem, Test, Her-2/neu, Ihc
Generic NameSystem, Test, Her-2/neu, Ihc
ApplicantDAKO A/S
Date Received2011-04-06
Decision Date2011-04-18
PMAP980018
SupplementS013
Product CodeMVC
Advisory CommitteePathology
Supplement TypeSpecial (immediate Track)
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
Expedited ReviewNo
Combination Product Yes
Applicant Address DAKO A/S 42 Produktionsvej glostrup DK-26-2600

Supplemental Filings

Supplement NumberDateSupplement Type
P980018Original Filing
S025 2020-06-04 30-day Notice
S024 2018-01-12 30-day Notice
S023 2016-12-27 Real-time Process
S022 2016-06-06 Real-time Process
S021 2016-02-29 Real-time Process
S020 2015-08-13 30-day Notice
S019 2015-04-27 30-day Notice
S018 2013-11-21 Special (immediate Track)
S017 2012-11-01 Normal 180 Day Track
S016 2012-08-24 Normal 180 Day Track
S015 2011-12-05 Normal 180 Day Track
S014 2011-08-15 30-day Notice
S013 2011-04-06 Special (immediate Track)
S012 2011-01-24 30-day Notice
S011 2010-09-09 Normal 180 Day Track
S010 2010-04-21 Panel Track
S009 2010-02-25 Real-time Process
S008 2010-02-12 30-day Notice
S007 2009-12-31 30-day Notice
S006 2008-05-28 Normal 180 Day Track
S005 2005-12-08 Special (immediate Track)
S004 2005-06-20 30-day Notice
S003 2004-11-10 Normal 180 Day Track No User Fee
S002 2003-05-14 30-day Notice
S001 2002-11-15 Real-time Process

NIH GUDID Devices

Device IDPMASupp
05700572032007 P980018 000
05700572031994 P980018 000
05700572031987 P980018 000

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