PMA P100024S001
- Device
- HER2 CISH PHARMADX KIT
- Applicant
- Dako Denmark A/S
- PMA number
- P100024
- Supplement
- S001
- Product code
- NYQ
- Decision date
- 2012-02-01
- Generic name
- Chromogenic in situ hybridization, nucleic acid amplification, HER2/NEU gene, breast cancer
- Approval order statement
- APPROVAL FOR AN UPDATE OF THE SOFTWARE DOCUMENTATION FOR DAKOLINK SOFTWARE VERSION 3.0 TO DAKOLINK VERSION 3.1.1.
Current openFDA PMA Record#
- Device
- HER2 CISH PHARMADX KIT
- Applicant
- Dako Denmark A/S
- PMA number
- P100024
- Supplement
- S001
- Product code
- NYQ
- Generic name
- Chromogenic in situ hybridization, nucleic acid amplification, HER2/NEU gene, breast cancer
- Decision date
- 2012-02-01
- Decision code
- APPR
- Date received
- 2011-12-07
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR AN UPDATE OF THE SOFTWARE DOCUMENTATION FOR DAKOLINK SOFTWARE VERSION 3.0 TO DAKOLINK VERSION 3.1.1.