PMA
P170005: Abbott RealTime IDH2
FDA PMA · Somatic gene mutation detection system · Abbott Molecular, Inc.
Key facts
| PMA number | P170005 |
|---|---|
| Trade name | Abbott RealTime IDH2 |
| Generic name | Somatic gene mutation detection system |
| Applicant | Abbott Molecular, Inc. |
| Owner/operator | ABBOTT LABORATORIES |
| Product code | OWD |
| Approval date | Aug 1, 2017 |
| Docket number | 17M-4757 |
| Notice date | Aug 28, 2017 |
| Establishment registration | 3005248192 |
| FEI number | 3005248192 |
At a glance
- 1–9 Supplements
- May 28, 2026 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 10–99 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: