PMA
P040030: INSITE HER-2/NEU KIT
FDA PMA · SYSTEM, TEST, HER-2/NEU, IHC · Biogenex Laboratories, Inc.
Key facts
| PMA number | P040030 |
|---|---|
| Trade name | INSITE HER-2/NEU KIT |
| Generic name | SYSTEM, TEST, HER-2/NEU, IHC |
| Applicant | Biogenex Laboratories, Inc. |
| Owner/operator | BIOGENEX LABORATORIES INC. |
| Product code | MVC |
| Approval date | Dec 22, 2004 |
| Docket number | 05M-0160 |
| Notice date | May 2, 2005 |
| Establishment registration | 3008776165 |
| FEI number | 2936532 |
At a glance
- None Supplements
- Dec 22, 2004 Latest supplement decision
- Yes Withdrawn
- Yes 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: