cobas® EZH2 Mutation Test
FDA premarket approval P200014/S009 · decided 2024-10-10
Approval details
- PMA number
- P200014
- Supplement
- S009
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- cobas® EZH2 Mutation Test
- Generic name
- Somatic gene mutation detection system
- Applicant
- Roche Molecular System, Inc.
- Date received
- 2024-09-11
- Decision date
- 2024-10-10
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- OWD
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Pleasanton, CA
- Statement
- manufacturing process change
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.