LeukoStrat CDx FLT3 Mutation Assay
FDA premarket approval P160040/S007 · decided 2021-08-26
Approval details
- PMA number
- P160040
- Supplement
- S007
- Supplement type
- Normal 180 Day 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
- 2020-12-02
- Decision date
- 2021-08-26
- Days to decision
- 267 days
- Decision code
- APPR
- Product code
- OWD
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- San Diego, CA
- Statement
- Approval for the improvement of the manufacturing method for the FLT3 TKD Positive Control included with the LeukoStrat CDx FLT3 Mutation Assay.
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