C-KIT PHARMDX

Immunohistochemistry Antibody Assay, C-kit

FDA Premarket Approval P040011 S002

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

Approval for changing the company prefix to the device name (from dakocytomation c-kit pharmdx to c-kit pharmdx). The device, as modified, will be marketed under the trade name c-kit pharmdx.

• 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: 2012-10-16
• Decision Date: 2012-11-02
• PMA: P040011
• Supplement: S002
• Product Code: NKF
• Advisory Committee: Pathology
• Supplement Type: Normal 180 Day Track No User Fee
• Supplement Reason: Labeling Change - Indications/instructions/shelf Life/tradename
• 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