PMA P100024S012
- Device
- HER2 CISH pharmDX Kit
- Applicant
- Dako Denmark A/S
- PMA number
- P100024
- Supplement
- S012
- Product code
- NYQ
- Decision date
- 2017-04-12
- Generic name
- Chromogenic in situ hybridization, nucleic acid amplification, HER2/NEU gene, breast cancer
- Approval order statement
- Changes to the in-process control fluorescent labeling process.
Current openFDA PMA Record#
- Device
- HER2 CISH pharmDX Kit
- Applicant
- Dako Denmark A/S
- PMA number
- P100024
- Supplement
- S012
- Product code
- NYQ
- Generic name
- Chromogenic in situ hybridization, nucleic acid amplification, HER2/NEU gene, breast cancer
- Decision date
- 2017-04-12
- Decision code
- OK30
- Date received
- 2017-03-13
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Changes to the in-process control fluorescent labeling process.