LeukoStrat CDx FLT3 Mutation Assay
FDA premarket approval P160040/S001 · decided 2018-01-19
Approval details
- PMA number
- P160040
- Supplement
- S001
- 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
- 2017-12-22
- Decision date
- 2018-01-19
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- OWD
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- San Diego, CA
- Statement
- Validation of the ABI instruments and minor corrections to the instructions for use.
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