PMA P200014S003
- Device
- cobas® EZH2 Mutation Test
- Applicant
- Roche Molecular System, Inc.
- PMA number
- P200014
- Supplement
- S003
- Product code
- OWD
- Decision date
- 2021-08-10
- Generic name
- Somatic gene mutation detection system
- Approval order statement
- Approval for the revised Instructions for Use for the cobas® EZH2 Mutation Test.
Current openFDA PMA Record#
- Device
- cobas® EZH2 Mutation Test
- Applicant
- Roche Molecular System, Inc.
- PMA number
- P200014
- Supplement
- S003
- Product code
- OWD
- Generic name
- Somatic gene mutation detection system
- Decision date
- 2021-08-10
- Decision code
- APPR
- Date received
- 2021-02-22
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Approval order statement
- Approval for the revised Instructions for Use for the cobas® EZH2 Mutation Test.