OSL — Control, Fecal Occult Blood Class II
FDA product code OSL covers "Control, Fecal Occult Blood", a Class II medical device regulated under 21 CFR 864.6550. Submissions are reviewed by the Hematology panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- OSL
- Device Class
- Class II
- Regulation Number
- 864.6550
- Submission Type
- Review Panel
- HE
- Medical Specialty
- Hematology
- Implant
- No
Definition
Fecal occult blood controls (Negative and positive) are used to verify the performance of the fecal occult blood test devices.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K101831 | bionostics | ENTERIX INSUREFIT FOB CONTROLS, MODEL 16800 | October 1, 2010 |