cobas® EZH2 Mutation Test
FDA premarket approval P200014/S006 · decided 2023-08-23
Approval details
- PMA number
- P200014
- Supplement
- S006
- 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
- 2023-07-25
- Decision date
- 2023-08-23
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- OWD
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Pleasanton, CA
- Statement
- Change manufacturing tolerances for a component.
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