LeukoStrat CDx FLT3 Mutation Assay
FDA premarket approval P160040/S013 · decided 2024-09-27
Approval details
- PMA number
- P160040
- Supplement
- S013
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- LeukoStrat CDx FLT3 Mutation Assay
- Generic name
- Somatic gene mutation detection system
- Applicant
- Invivoscribe Technologies, Inc.
- Date received
- 2024-09-04
- Decision date
- 2024-09-27
- Days to decision
- 23 days
- Decision code
- APPR
- Product code
- OWD
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- San Diego, CA
- Statement
- approval for use of any cell counter for use with the LeukoStrat CDx FLT3 Mutation Assay
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