PMA P040011S002

Device: C-KIT PHARMDX
Applicant: Dako North America, Inc.
PMA number: P040011
Supplement: S002
Product code: NKF
Decision date: 2012-11-02
Classification: Immunohistochemistry Antibody Assay, C-kit
Generic name: Immunohistochemistry antibody assay, c-kit
Approval order statement: 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.

Current openFDA PMA Record#

Device: C-KIT PHARMDX
Applicant: Dako North America, Inc.
PMA number: P040011
Supplement: S002
Product code: NKF
Generic name: Immunohistochemistry antibody assay, c-kit
Decision date: 2012-11-02
Decision code: APPR
Date received: 2012-10-16
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: 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.