C-Kit pharmDx

Immunohistochemistry Antibody Assay, C-kit

FDA Premarket Approval P040011 S003

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

Changes to the relocation/ expansion of facility.

• Device: C-Kit pharmDx
• Classification Name: Immunohistochemistry Antibody Assay, C-kit
• Generic Name: Immunohistochemistry Antibody Assay, C-kit
• Applicant: DAKO NORTH AMERICA, INC.
• Date Received: 2017-04-17
• Decision Date: 2017-05-16
• PMA: P040011
• Supplement: S003
• Product Code: NKF
• 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
P040011		Original Filing
S003	2017-04-17	30-day Notice
S002	2012-10-16	Normal 180 Day Track No User Fee
S001	2007-03-29	30-day Notice

NIH GUDID Devices

Device ID	PMA	Supp
05700571104057	P040011	000
05700571104040	P040011	000