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C-Kit PharmDx Immunohistochemistry Antibody Assay

by Dako North America, Inc. PMA

Withdrawn United States

PMA P040011

Regulatory status

as of 29 Oct 2026

Withdrawn since 27 Jun 2005. The authorization below is no longer in force.

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPWD Approval withdrawn NumberP040011 Date27 Jun 2005Approval withdrawnStatusWithdrawn

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA PMA Withdrawn

Recalls

0 recalls · FDA

No FDA recalls on record, checked 6 Oct 2026.

Specification

PMA

Full name
C-Kit pharmDx
Generic Name
Immunohistochemistry antibody assay, c-kit
PMA Number
FDA Product Code
NKF
Device Class
Class III
Regulation
21 CFR Part 864.1860
Advisory Committee
Pathology
FDA Decision
APWD Approval withdrawn

Other devices from Dako North America, Inc.