PMA
P120004: PARASCRIPT ACCUDETECT 6.1.0
FDA PMA · Analyzer, medical image · Parascript, LLC
Key facts
| PMA number | P120004 |
|---|---|
| Trade name | PARASCRIPT ACCUDETECT 6.1.0 |
| Generic name | Analyzer, medical image |
| Applicant | Parascript, LLC |
| Product code | MYN |
| Approval date | Aug 22, 2013 |
| Docket number | 13M-1017 |
| Notice date | Sep 10, 2013 |
| FEI number | 3009670842 |
At a glance
- 1–9 Supplements
- Oct 16, 2015 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- No Withdrawn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: