PMA
P940035: NMP22 BladderChek Test
FDA PMA · System, test, tumor marker, for detection of bladder cancer · Abbott Diagnostics Scarborough, Inc.
Key facts
| PMA number | P940035 |
|---|---|
| Trade name | NMP22 BladderChek Test |
| Generic name | System, test, tumor marker, for detection of bladder cancer |
| Applicant | Abbott Diagnostics Scarborough, Inc. |
| Owner/operator | ABBOTT LABORATORIES |
| Product code | NAH |
| Approval date | Jul 2, 1996 |
| Docket number | 96M-0462 |
| Notice date | Dec 9, 1996 |
| Establishment registration | 1221359 |
| FEI number | 1221359 |
At a glance
- 10–99 Supplements
- Jul 12, 2022 Latest supplement decision
- No Withdrawn
- No 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: