Fecal Occult Blood Card Test (F735-A +2 more)
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K061065 FDA 510(k)
- FDA Product Code
- KHE FDA 510(k)
- Models / Variants
- F735-A FDA 510(k)Fecal Occult Blood Card Kit FDA 510(k)Model F735-25 FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 864.6550 FDA 510(k)
- Regulation Number
- 864.6550 FDA 510(k)
- Advisory Committee
- Hematology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Fecal Occult Blood Card Test is an immunochromatographic reagent designed for the qualitative detection of human hemoglobin in fecal samples. Classified as a reagent for occult blood testing, it aids in identifying gastrointestinal bleeding associated with conditions such as colorectal carcinoma, polyps, diverticulitis, or ulcerative colitis. The assay provides a rapid, professional-grade method for screening in laboratory or clinical settings.
Supplied as single-use cards or kits (Model F735-25), the device requires no sterilization and is intended for in vitro diagnostic use only. It is not MRI-compatible and must be stored according to manufacturer instructions to maintain integrity. Authorized under FDA 510(k) clearance (K061065) as substantially equivalent, the test adheres to regulatory standards for hematology diagnostics under classification II (KHE). No third-party reprocessing is permitted.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Fecal Occult Blood Card Test, Model F735-a, Fecal Occult Blood Card Kit ..., Fecal Occult Blood Card Test, Model F735-a, Fecal Occult Blood Card Kit ..., F735-25 - Teco Diagnostics, Rapid fecal occult blood test - F735-25 - Teco Diagnostics - MedicalExpo
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K061065 | Class II | Active |
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Manufacturer
- Manufacturer
- Teco Diagnostics
Sources (1)
- FDA 510(k) K061065 24 fields · synced Oct 6, 2026