OSL
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Control, Fecal Occult Blood
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.6550
- Medical specialty
- Hematology
- FDA definition
- Fecal occult blood controls (Negative and positive) are used to verify the performance of the fecal occult blood test devices.
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| Record | Firm | Date | Builder |
|---|---|---|---|
| ENTERIX INSUREFIT FOB CONTROLS, MODEL 16800 (K101831) | Bionostics, Inc. | 2010-10-01 | + Add |
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