PMA
P840065: COBAS BACT
FDA PMA · SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION · Roche Diagnostics GmbH
Key facts
| PMA number | P840065 |
|---|---|
| Trade name | COBAS BACT |
| Generic name | SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION |
| Applicant | Roche Diagnostics GmbH |
| Owner/operator | Roche Diagnostics Operations Inc. |
| Product code | LON |
| Approval date | May 30, 1986 |
| Docket number | 86M-0249 |
| Notice date | Jul 7, 1986 |
| Establishment registration | 3003795116 |
| FEI number | 3003795116 |
At a glance
- None Supplements
- May 30, 1986 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- No Withdrawn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: