PMA
P160040: LeukoStrat CDx FLT3 Mutation Assay
FDA PMA · Somatic gene mutation detection system · Invivoscribe Technologies, Inc.
Key facts
| PMA number | P160040 |
|---|---|
| Trade name | LeukoStrat CDx FLT3 Mutation Assay |
| Generic name | Somatic gene mutation detection system |
| Applicant | Invivoscribe Technologies, Inc. |
| Owner/operator | Invivoscribe, Inc. |
| Product code | OWD |
| Approval date | Apr 28, 2017 |
| Docket number | 17M-2766 |
| Notice date | May 18, 2017 |
| Establishment registration | 3014173060 |
| FEI number | 3014173060 |
At a glance
- 10–99 Supplements
- Sep 27, 2024 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 1–9 UDI device identifiers (GUDID)
- None MAUDE adverse event reports
- None Recall events
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA approvals
Premarket approval (PMA) is the FDA's most stringent review pathway, required for most Class III devices that support or sustain life or present a potentially unreasonable risk.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: