LeukoStrat CDx FLT3 Mutation Assay
FDA premarket approval P160040/S003 · decided 2018-12-07
Approval details
- PMA number
- P160040
- Supplement
- S003
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location 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
- 2018-04-12
- Decision date
- 2018-12-07
- Days to decision
- 239 days
- Decision code
- APPR
- Product code
- OWD
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- San Diego, CA
- Statement
- Approval for a manufacturing site located at Invivoscribe Technologies, Inc., 10222 Barnes Canyon Rd., Bldg. 1, San Diego, California.
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