PD-L1 IHC 22C3 pharmDx

FDA Premarket Approval P150013 S017

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

Approved to migrate the pd-l1 ihc 22c3 pharmdx assay for nsclc indication for use on the dako omnis automated staining system per approval letter.

DevicePD-L1 IHC 22C3 pharmDx
Generic NameImmunohistochemistry Assay, Antibody, Programmed Death-ligand 1
ApplicantDAKO NORTH AMERICA, INC.
Date Received2019-06-14
Decision Date2020-03-19
PMAP150013
SupplementS017
Product CodePLS 
Advisory CommitteePathology
Supplement TypeNormal 180 Day Track
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination Product No
Applicant Address DAKO NORTH AMERICA, INC. 6392 Via Real carpinteria, CA 93013

Supplemental Filings

Supplement NumberDateSupplement Type
P150013Original Filing
S018 2019-09-05 Normal 180 Day Track No User Fee
S017 2019-06-14 Normal 180 Day Track
S016 2019-02-25 Panel Track
S015 2019-02-15 30-day Notice
S014
S013 2018-12-21 30-day Notice
S012
S011 2018-06-25 Panel Track
S010 2018-03-12 30-day Notice
S009 2018-01-29 Panel Track
S008 2017-12-26 30-day Notice
S007 2017-09-21 Normal 180 Day Track No User Fee
S006 2017-04-19 Panel Track
S005 2017-04-17 30-day Notice
S004 2016-12-27 Real-time Process
S003 2016-08-19 Real-time Process
S002 2016-06-28 Real-time Process
S001 2015-12-31 Panel Track

NIH GUDID Devices

Device IDPMASupp
05700571107300 P150013 000

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