Roche cobas® EZH2 Mutation Test
FDA premarket approval P200014/S008 · decided 2023-12-21
Approval details
- PMA number
- P200014
- Supplement
- S008
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Roche cobas® EZH2 Mutation Test
- Generic name
- Somatic gene mutation detection system
- Applicant
- Roche Molecular System, Inc.
- Date received
- 2023-12-07
- Decision date
- 2023-12-21
- Days to decision
- 14 days
- Decision code
- APPR
- Product code
- OWD
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Pleasanton, CA
- Statement
- Approval for described labeling changes in an update to the hazard information on the product labeling for cobas® KRAS Mutation Test and the cobas® DNASample Preparation Kit.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.