EGFR pharmDx

Immunohistochemistry Assay, Antibody, Epidermal Growth Factor Receptor

FDA Premarket Approval P030044 S006

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

Implementation of an in-process qc specification.

DeviceEGFR pharmDx
Classification NameImmunohistochemistry Assay, Antibody, Epidermal Growth Factor Receptor
Generic NameImmunohistochemistry Assay, Antibody, Epidermal Growth Factor Receptor
ApplicantDAKO NORTH AMERICA, INC.
Date Received2018-12-21
Decision Date2019-01-17
PMAP030044
SupplementS006
Product CodeNQF
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
P030044Original Filing
S007 2019-02-15 30-day Notice
S006 2018-12-21 30-day Notice
S005 2018-03-12 30-day Notice
S004 2017-12-26 30-day Notice
S003 2017-04-17 30-day Notice
S002 2006-04-03 Normal 180 Day Track
S001 2005-11-17 Real-time Process

NIH GUDID Devices

Device IDPMASupp
05700571103982 P030044 000
05700571103968 P030044 000

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