PMA
P800029: API 3600S ANTIMICROBIAL SUSCEPTIBILITY SYSTEM
FDA PMA · SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION · Analytical Products, Inc.
Key facts
| PMA number | P800029 |
|---|---|
| Trade name | API 3600S ANTIMICROBIAL SUSCEPTIBILITY SYSTEM |
| Generic name | SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION |
| Applicant | Analytical Products, Inc. |
| Product code | LON |
| Approval date | Jan 30, 1981 |
| Notice date | Apr 28, 1981 |
At a glance
- 1–9 Supplements
- May 4, 1984 Latest supplement decision
- No Withdrawn
- No Summary of safety and effectiveness on file
- None 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: