PMA
P870049: MICROSCAN RAPID PANELS
FDA PMA · SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION · Dade Intl., Inc.
Key facts
| PMA number | P870049 |
|---|---|
| Trade name | MICROSCAN RAPID PANELS |
| Generic name | SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION |
| Applicant | Dade Intl., Inc. |
| Owner/operator | BECKMAN COULTER, INC. |
| Product code | LON |
| Approval date | Feb 24, 1988 |
| Docket number | 88M-0083 |
| Notice date | Apr 11, 1988 |
| Establishment registration | 2919016 |
| FEI number | 2919016 |
At a glance
- 10–99 Supplements
- Nov 30, 2001 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- No Withdrawn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: