cobas® EZH2 Mutation Test
FDA premarket approval P200014/S001 · decided 2020-08-26
Approval details
- PMA number
- P200014
- Supplement
- S001
- 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
- 2020-07-27
- Decision date
- 2020-08-26
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- OWD
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Pleasanton, CA
- Statement
- Manufacturing process change to use an alternate filter
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