Control, Fecal Occult Blood
FDA product code OSL · Class II (moderate risk) · 21 CFR 864.6550 · Hematology
Fecal occult blood controls (Negative and positive) are used to verify the performance of the fecal occult blood test devices.
1510(k) clearances
0PMA approvals
0recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K101831 | Enterix Insurefit Fob Controls, Model 16800OSL · Traditional | Bionostics, Inc. | 10/01/2010SE |