# K061065: Fecal Occult Blood Card Test, Model F735-a, Fecal Occult Blood Card Kit, Model F735-25

- Pathway: 510(k) (Traditional)
- Applicant: Teco Diagnostics
- Decided: Jul 14, 2006 after 88 days
- Product code: KHE (Reagent, Occult Blood)
- Device class: 2
- Regulation: 21 CFR 864.6550
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Indications for use
Teco Rapid Fecal Occult Blood (FOB) Card Test is an immunochromatographic assay intended for the determination of human hemoglobin in feces by professional laboratories or physicians offices. It is useful to determining gastrointestinal bleeding found in a number of gastrointestinal disorders such as colorectal carcinoma, colon polyps, diverticulitis and ulcerative colitis. Teco Rapid Fecal Occult Blood (FOB) Card Test is recommended for use in 1) routine physical examination 2) hospital monitoring for bleeding in patients, 3) screening for colorectal cancer or gastrointestinal bleeding from any source.

Source page: https://510kreport.com/device/K061065
Methodology: https://510kreport.com/methodology