PMA P100024S010
- Device
- HER2 CISH PHARMDX KIT
- Applicant
- Dako Denmark A/S
- PMA number
- P100024
- Supplement
- S010
- Product code
- NYQ
- Decision date
- 2016-09-27
- Generic name
- Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer
- Approval order statement
- Approval for the DakoLink software version 4.1 update for the HER2 CISH pharmDx Kit
Current openFDA PMA Record#
- Device
- HER2 CISH PHARMDX KIT
- Applicant
- Dako Denmark A/S
- PMA number
- P100024
- Supplement
- S010
- Product code
- NYQ
- Generic name
- Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer
- Decision date
- 2016-09-27
- Decision code
- APPR
- Date received
- 2016-07-01
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for the DakoLink software version 4.1 update for the HER2 CISH pharmDx Kit