Product code
PDJ: Hemoglobin a1c test system
FDA product code · Class II · Clinical Chemistry
Key facts
| Product code | PDJ |
|---|---|
| Device | Hemoglobin a1c test system |
| Device class | Class II |
| Regulation number | 862.1373 |
| Review panel | Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Submission type | 510(k) |
| GMP exempt | No |
| Implanted device | No |
| Life-sustaining or life-supporting | No |
| Definition | Quantitative determination of Hemoglobin A1c to aid in the diagnosis of diabetes. |
At a glance
- 10–99 510(k) clearances
- 1–9 De Novo grants
- None PMA approvals
- None HDE approvals
- 10–99 UDI devices (GUDID)
- 100–999 MAUDE adverse event reports
- 1–9 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