OOX

Automated Occult Blood Analyzer

Product code

OOX

Device name

Automated Occult Blood Analyzer

Device class

Class 2

21 CFR

21 CFR 864.6550

Medical specialty

Hematology

Marketing pathway

510(K)

Flag

Third-party review eligible

510(k) clearances (all years, FDA)

6 (all years; only the last 3 years are listed here)

FDA classification definition

The automated test system is intended for the qualitative detection of fecal occult blood in feces by professional laboratories. The automated test is used for the determination of gastrointestinal bleeding.

Definition text from the FDA device classification database (U.S. federal government work, public domain).