cobas® EZH2 Mutation Test
FDA premarket approval P200014/S004 · decided 2022-11-29
Approval details
- PMA number
- P200014
- Supplement
- S004
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- cobas® EZH2 Mutation Test
- Applicant
- Roche Molecular System, Inc.
- Date received
- 2022-10-18
- Decision date
- 2022-11-29
- Days to decision
- 42 days
- Decision code
- OK30
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Pleasanton, CA
- Statement
- Discontinuation of redundant pH testing for vialed Paraffin Binding Buffer.
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