PD-L1 IHC 28-8 pharmDx

Immunohistochemistry Assay, Antibody, Programmed Death-ligand 1

FDA Premarket Approval P150025 S009

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

Modification of manufacturing equipment and process.

DevicePD-L1 IHC 28-8 pharmDx
Classification NameImmunohistochemistry Assay, Antibody, Programmed Death-ligand 1
Generic NameImmunohistochemistry Assay, Antibody, Programmed Death-ligand 1
ApplicantDAKO NORTH AMERICA, INC.
Date Received2018-03-12
Decision Date2018-04-10
PMAP150025
SupplementS009
Product CodePLS
Advisory CommitteePathology
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address DAKO NORTH AMERICA, INC. 6392 Via Real carpinteria, CA 93013

Supplemental Filings

Supplement NumberDateSupplement Type
P150025Original Filing
S015 2022-06-17 30-day Notice
S014 2021-07-12 Normal 180 Day Track
S013 2019-12-16 Panel Track
S012
S011 2019-02-15 30-day Notice
S010 2018-12-21 30-day Notice
S009 2018-03-12 30-day Notice
S008 2017-12-26 30-day Notice
S007
S006 2017-04-17 30-day Notice
S005 2016-12-29 Normal 180 Day Track No User Fee
S004 2016-12-27 Real-time Process
S003 2016-12-22 Panel Track
S002 2016-08-19 Real-time Process
S001 2016-07-07 Real-time Process

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