LeukoStrat CDx FLT3 Mutation Assay
FDA premarket approval P160040/S009 · decided 2021-08-11
Approval details
- PMA number
- P160040
- Supplement
- S009
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- LeukoStrat CDx FLT3 Mutation Assay
- Generic name
- Somatic gene mutation detection system
- Applicant
- Invivoscribe Technologies, Inc.
- Date received
- 2021-07-12
- Decision date
- 2021-08-11
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- OWD
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- San Diego, CA
- Statement
- Qualification of an automated process for fill, finish, and label the kit components.
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