PMA P100024S013
- Device
- HER2 CISH pharmDx Kit
- Applicant
- Dako Denmark A/S
- PMA number
- P100024
- Supplement
- S013
- Product code
- NYQ
- Decision date
- 2017-04-03
- Generic name
- Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer
- Approval order statement
- Change in the mixing process for preparation of a probe component.
Current openFDA PMA Record#
- Device
- HER2 CISH pharmDx Kit
- Applicant
- Dako Denmark A/S
- PMA number
- P100024
- Supplement
- S013
- Product code
- NYQ
- Generic name
- Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer
- Decision date
- 2017-04-03
- Decision code
- OK30
- Date received
- 2017-03-13
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change in the mixing process for preparation of a probe component.