cobas® EZH2 Mutation Test
FDA premarket approval P200014/S003 · decided 2021-08-10
Approval details
- PMA number
- P200014
- Supplement
- S003
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Trade name
- cobas® EZH2 Mutation Test
- Generic name
- Somatic gene mutation detection system
- Applicant
- Roche Molecular System, Inc.
- Date received
- 2021-02-22
- Decision date
- 2021-08-10
- Days to decision
- 169 days
- Decision code
- APPR
- Product code
- OWD
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Pleasanton, CA
- Statement
- Approval for the revised Instructions for Use for the cobas® EZH2 Mutation Test.
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