OSL

Control, Fecal Occult Blood

Product code

OSL

Device name

Control, Fecal Occult Blood

Device class

Class 2

21 CFR

21 CFR 864.6550

Medical specialty

Hematology

Marketing pathway

510(K) Exempt

510(k) clearances (all years, FDA)

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

FDA classification definition

Fecal occult blood controls (Negative and positive) are used to verify the performance of the fecal occult blood test devices.

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