Cleared Traditional

ENTERIX INSUREFIT FOB CONTROLS, MODEL 16800

K101831 · Bionostics, Inc. · Hematology

Oct 2010

Decision

92d

Days

Class 2

Risk

About This 510(k) Submission

K101831 is an FDA 510(k) clearance for the ENTERIX INSUREFIT FOB CONTROLS, MODEL 16800, a Control, Fecal Occult Blood (Class II — Special Controls, product code OSL), submitted by Bionostics, Inc. (Devens, US). The FDA issued a Cleared decision on October 1, 2010, 92 days after receiving the submission on July 1, 2010. This device falls under the Hematology review panel. Regulated under 21 CFR 864.6550.

Submission Details

510(k) Number	K101831 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 01, 2010
Decision Date	October 01, 2010
Days to Decision	92 days
Submission Type	Traditional
Review Panel	Hematology (HE)
Summary	Summary PDF

Device Classification

Product Code	OSL — Control, Fecal Occult Blood
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 864.6550
Definition	Fecal Occult Blood Controls (negative And Positive) Are Used To Verify The Performance Of The Fecal Occult Blood Test Devices.