Product code
OSL: Control, fecal occult blood
FDA product code · Class II · Hematology
Key facts
| Product code | OSL |
|---|---|
| Device | Control, fecal occult blood |
| Device class | Class II |
| Regulation number | 864.6550 |
| Review panel | Hematology |
| Medical specialty | Hematology |
| Submission type | 510(K) Exempt |
| GMP exempt | No |
| Implanted device | No |
| Life-sustaining or life-supporting | No |
| Definition | Fecal occult blood controls (Negative and positive) are used to verify the performance of the fecal occult blood test devices. |
At a glance
- 1–9 510(k) clearances
- None De Novo grants
- None PMA approvals
- None HDE approvals
- 1–9 UDI devices (GUDID)
- 1–9 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