PMA
P940036: BARTELS CHEMORESPONSE ASSAY
FDA PMA · Test, anti-tumor cell susceptibility · Bartels Prognostics, Inc.
Key facts
| PMA number | P940036 |
|---|---|
| Trade name | BARTELS CHEMORESPONSE ASSAY |
| Generic name | Test, anti-tumor cell susceptibility |
| Applicant | Bartels Prognostics, Inc. |
| Product code | MHR |
| Approval date | Aug 1, 1996 |
| Docket number | 96M-0471 |
| Notice date | Dec 17, 1996 |
At a glance
- None Supplements
- Aug 1, 1996 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- No Withdrawn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: