LeukoStrat® CDx FL T3 Mutation Assay
FDA premarket approval P160040/S012 · decided 2023-02-06
Approval details
- PMA number
- P160040
- Supplement
- S012
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- LeukoStrat® CDx FL T3 Mutation Assay
- Generic name
- Somatic gene mutation detection system
- Applicant
- Invivoscribe Technologies, Inc.
- Date received
- 2022-11-14
- Decision date
- 2023-02-06
- Days to decision
- 84 days
- Decision code
- APPR
- Product code
- OWD
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- San Diego, CA
- Statement
- Approval for replacing NEBuffer 3.1, containing bovine serum albumin, with NEBuffer r3.1, containing recombinant (non-bovine) albumin in the LeukoStrat® CDx FLT3 Mutation Assay kit configuration.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.