DeviceClearance

Product code OSL— Hematology

ENTERIX INSUREFIT FOB CONTROLS, MODEL 16800

Classification name
Control, Fecal Occult Blood
Device class
Class 2
Regulation
21 CFR 864.6550
Advisory panel
Hematology
Total cleared
1
First cleared
Most recent

FDA classification definition

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

— U.S. Food and Drug Administration, device classification record for product code OSL under 21 CFR 864.6550, via openFDA

Market context for product code OSL

FDA has cleared 1 device under product code OSL, all in 2010, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code OSL

Recent clearances under product code OSL

Data sourced from openFDA. This site is unofficial and independent of the FDA.