PMA P110027S011
- Device
- therascreen KRAS RGQ PCR Kit
- Applicant
- QIAGEN GmbH
- PMA number
- P110027
- Supplement
- S011
- Product code
- OWD
- Decision date
- 2020-04-03
- Generic name
- Somatic gene mutation detection system
- Approval order statement
- Changes to in-process QC testing.
Current openFDA PMA Record#
- Device
- therascreen KRAS RGQ PCR Kit
- Applicant
- QIAGEN GmbH
- PMA number
- P110027
- Supplement
- S011
- Product code
- OWD
- Generic name
- Somatic gene mutation detection system
- Decision date
- 2020-04-03
- Decision code
- OK30
- Date received
- 2020-03-04
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Changes to in-process QC testing.