LeukoStrat CDx FLT3 Mutation Assay
FDA premarket approval P160040/S010 · decided 2022-04-11
Approval details
- PMA number
- P160040
- Supplement
- S010
- 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
- 2022-03-15
- Decision date
- 2022-04-11
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- OWD
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- San Diego, CA
- Statement
- Change of contractor mycoplasma testing method for Invivoscribe cell lines.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.