PMA P100024S011
- Device
- HER2 CISH PHARMDX KIT
- Applicant
- Dako Denmark A/S
- PMA number
- P100024
- Supplement
- S011
- Product code
- NYQ
- Decision date
- 2017-03-24
- Generic name
- Chromogenic in situ hybridization, nucleic acid amplification, HER2/NEU gene, breast cancer
- Approval order statement
- Approval for an update to DakoLink software version 4.2.
Current openFDA PMA Record#
- Device
- HER2 CISH PHARMDX KIT
- Applicant
- Dako Denmark A/S
- PMA number
- P100024
- Supplement
- S011
- Product code
- NYQ
- Generic name
- Chromogenic in situ hybridization, nucleic acid amplification, HER2/NEU gene, breast cancer
- Decision date
- 2017-03-24
- Decision code
- APPR
- Date received
- 2016-12-27
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for an update to DakoLink software version 4.2.