Product code
PKM: Chemiluminescent immunoassay system
FDA product code · Not Classified · Toxicology
Key facts
| Product code | PKM |
|---|---|
| Device | Chemiluminescent immunoassay system |
| Device class | Not Classified |
| Review panel | Toxicology |
| Submission type | Contact ODE |
| GMP exempt | No |
| Implanted device | No |
| Life-sustaining or life-supporting | No |
| Definition | For in vitro diagnostic use in the quantitative measurement of hyaluronic acid in human serum. |
At a glance
- None 510(k) clearances
- None De Novo grants
- None PMA approvals
- None HDE approvals
- None UDI devices (GUDID)
- None MAUDE adverse event reports
- None Recalled products (Z-numbers)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device product codes
FDA product codes classify medical devices by type and intended use; each code maps to a device class, a classification regulation and a review panel.
Source: U.S. Food and Drug Administration (FDA), Product Classification database