PMA P200014S004
- Device
- cobas® EZH2 Mutation Test
- Applicant
- Roche Molecular System, Inc.
- PMA number
- P200014
- Supplement
- S004
- Decision date
- 2022-11-29
- Approval order statement
- Discontinuation of redundant pH testing for vialed Paraffin Binding Buffer.
Current openFDA PMA Record#
- Device
- cobas® EZH2 Mutation Test
- Applicant
- Roche Molecular System, Inc.
- PMA number
- P200014
- Supplement
- S004
- Decision date
- 2022-11-29
- Decision code
- OK30
- Date received
- 2022-10-18
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Discontinuation of redundant pH testing for vialed Paraffin Binding Buffer.