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.

• Device: EGFR pharmDx
• Classification Name: Immunohistochemistry Assay, Antibody, Epidermal Growth Factor Receptor
• Generic Name: Immunohistochemistry Assay, Antibody, Epidermal Growth Factor Receptor
• Applicant: DAKO NORTH AMERICA, INC.
• Date Received: 2018-12-21
• Decision Date: 2019-01-17
• PMA: P030044
• Supplement: S006
• Product Code: NQF
• Advisory Committee: Pathology
• Supplement Type: 30-day Notice
• Supplement Reason: Process Change - Manufacturer/sterilizer/packager/supplier
• Expedited Review: No
• Combination Product: No
• Applicant Address: DAKO NORTH AMERICA, INC. 6392 Via Real carpinteria, CA 93013

Supplemental Filings

Supplement Number	Date	Supplement Type
P030044		Original 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 ID	PMA	Supp
05700571103982	P030044	000
05700571103968	P030044	000